SecondLook Digital for Philips DR Labeling and User Manual For
Contents
1. 3 The third page then presents a summary of the case which includes the case history the mammographic findings and the resulting pathology An arrow points to the location of the tumor in printed versions of the mammograms DTM094 iCAD Inc Page 17 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A 4 2 Sample Case Case History and Mammograms History 62 yo female with palpable mass in upper outer quadrant of right breast No family history of breast cancer TT DURING CLINICAL USE THE INITIAL MAMMOGRAPHY REVIEW AND ae TT INITIAL WORK UP DECISION WOULD BE ACCOMPLISHED GE DTM094 iCAD Inc Page 18 of 23 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A Mammograms with CAD Marks Note The softcopy review workstation may use symbols other than rectangles calcifications and ellipses masses for the CAD marks rr DURING CLINICAL USE THE AREAS OF CONCERN HIGHLIGHTED BY TT THE CAD MARKS WOULD BE RE EVALUATED USING THE SOFTCOPY ees REVIEW WORKSTATION FROM THIS RE EVALUATION OF THE Kee TT MAMMOGRAMS THE RADIOLOGIST MAKES THE FINAL WORK UP Kate TT DECISION jii DTM094 iCAD Inc Page 19 of 23 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A Case Summary History 62 yo female with palpable mass in upper outer quadrant of right breast No family history of breast cancer Mammographic2. CAD Never stop looking SecondLook Digital for Philips DR Labeling and User Manual For Use Outside The USA 2010 iCAD Inc All Rights Reserved iCAD the iCAD logo Never Stop Looking and SecondLook are registered trademarks of iCAD Inc Other company product and service names may be trademarks or service marks of others DTM094 Rev A SecondLook Digital for Philips DR Labeling and User Manual Rev A This page intentionally left blank DTM094 iCAD Inc Page 2 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A 1 CAD d Never stop looking 98 Spit Brook Rd Suite 100 Nashua NH 03062 USA 1 603 882 5200 The European Representative for iCAD Inc is CE D MDSS Gmbh Schiffgraben 41 30175 Hannover Germany For information regarding trainings for this device please contact Philips Customer Service or Philips Medical Systems DMC GmbH Rontgenstrakke 24 D 22335 Hamburg Germany email helpdesk xray gxr philips com DTM094 iCAD Inc Page 3 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A This page intentionally left blank DTM094 iCAD Inc Page 4 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 2 9 3 1 3 2 4 1 4 2 DTM094 E Ee AEN SEENEN sxessvevauecbuciecs sve shvcusuy eves vevinncb
3. 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A Benchmark testing Benchmark testing consisted of a standalone analysis i e analysis of the device without radiologist interaction on a sample of Philips FFDM images Note that standalone performance testing of SecondLook version 7 2 on Philips images cannot be directly compared to standalone performance testing of SecondLook on digitized film screen images The benchmark testing did not measure the effect of the device on radiologist performance and cannot measure or predict any change in radiologist s cancer detection rates when using the device as intended Benchmark testing of the SecondLook version 7 2 with FFDM images provides a performance measure i e sensitivity and average number of false positives per image or case in the absence of any interaction with a radiologist Standalone performance measures how often the CAD device places prompts over regions that contain or do not contain known breast abnormalities i e microcalcifications and or masses in the absence of radiologist interaction Results of SecondLook benchmark testing are as follows e Overall sensitivity of SecondLook at the high operating point was 87 95 Cl 80 94 e Overall average false positive rate of SecondLook at the high operating point was 1 97 CAD marks per 4 view screening exam 95 Cl 1 83 2 55 e Overall sensitivity of SecondLook at the medium operating point was
4. 87 95 Cl 80 94 e Overall average false positive rate of SecondLook at the medium operating point was 1 65 CAD marks per 4 view screening exam 95 Cl 1 55 2 15 2 7 Detailed Device Description SecondLook uses computer aided detection CAD algorithms to identify regions of interest on mammograms that may contain suspicious finding The CAD algorithms use advanced image processing feature computations and pattern recognition technology to analyze the images for potential areas of concern These potential areas of concern are displayed for the radiologist by overlaying CAD marks at the appropriate locations of the mammography images within the softcopy review workstation or on a paper printout The CAD marks are used by the radiologist as an additional tool in breast cancer detection DTM094 iCAD Inc Page 11 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A An overview of the SecondLook CAD algorithms is shown in Figure 1 below Standard Mammography Images MicroCalc Density Algorithm Algorithm Calc Image Density Image Enhancement Enhancement MicroCalc Density Detector Detector i Region Clustering Growing MicroCalc Density Classifier Classifier l D Context Based Patient Evaluation Areas of Concern Highlighted by CAD Marks Figure 1 SecondLook CAD Algorithms
5. Overview The CAD algorithms begin with image enhancement of the digitized mammographic images to accentuate all areas that could be individual microcalcifications and densities In the case of directly acquired images the digital images are first transformed into images that resemble digitized film in order to accommodate variations in inter pixel spacing gray level mapping and bit depth It should be noted that the Modulation Transfer Function MTF for Philips images deviates from the MTF specified for SecondLook in the high frequency range While the MTF is not directly used in the calculations performed by SecondLook this deviation may impact the calculation of subtle features along the margins of lesions The microcalcification and density detectors then identify the areas that are most likely to be individual microcalcifications and densities based on an initial analysis of morphological and intensity measurements The types of densities detected are depicted in Figure 2 and include spiculated and non spiculated masses architectural distortions and focal densities DTM094 iCAD Inc Page 12 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A Circumscribed Masses Round Oval Lobular Irregular Mass with Indistinct Margins fe T wa Spiculated Mass Architectural Distortion Microlobulated Mass Obscured Mass OZ Figure 2 Densities Detected by SecondLook Fu
6. of computer aided detection in interpretation of screening mammography AJR 2006 187 1483 1491 18 Fenton JJ Taplin SH Carney PA et al Influence of computer aided detection on performance of screening mammography NEJM 2007 356 1399 1409 19 Georgian Smith D Moore RH Halpern E et al Blinded comparison of computer aided detection with human second reading in screening mammography AJR 2007 189 1135 1141 20 Gromet M Comparison of Computer Aided Detection to Double Reading of Screening Mammograms Review of 231 221 Mammograms AJR 2008 190 854 859 21 Brem RF Baum J Lechner M et al Improvement in sensitivity of screening mammography with computer aided detection a multiinstitutional trial AJR 2003 181 687 693 22 Destounis SV DiNitto P Logan Young W et al Can computer aided detection with double reading of screening mammograms help decrease the false negative rate Initial experience Radiology 2004 232 578 584 23 Gilbert FJ Astley SM McGee MA et al Single Reading with Computer Aided Detection and Double Reading of Screening Mammograms in the United Kingdom National Breast Screening Program Radiology 241 pp 47 53 2006 24 Balleyguier C Kinkel K Fermanian J et al Computer aided detection CAD in mammography does it help the junior or the senior radiologist European Journal of Radiology 2005 54 90 96 25 Marx C Malich A Facius M et al Are unnecessary follow up procedures induced by co
7. of the mammogram and only after completing the conventional read the radiologist may choose to display the CAD marks which may prompt to areas that were or were not examined during the first read It is crucial to understand that 99 6 of all CAD marks will be placed over areas that are normal breast tissue or benign findings Be aware that the SecondLook is not a diagnostic device as the CAD marks are intended to be used to assist only in detection and not to assist with interpretation 2 3 Warnings AS Warnings Radiological Interpretation e The radiologist must always first perform a full conventional read of the mammogram and only after completing the conventional read the radiologist may choose to display the CAD marks which may prompt to areas that were or were not examined during the first read e The presence or absence of a CAD mark should not in any manner influence your diagnostic decision as to the nature of a mammographic finding i e normal vs benign vs malignant or the clinical action to be taken e g additional imaging or biopsy e Do not rely on the size or shape of the CAD mark as it may not be representative of the actual extent or shape of the breast lesion e Upon re evaluation for the original mammogram at the locations indicated by SecondLook the radiologist must use their interpretative skills to determine if the area should be worked up based on its mammographic appearance e SecondLook is neither d
8. current list of approved OS patches is available at www icadmed com or through an authorized re seller of iCAD products DTM094 iCAD Inc Page 15 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A 3 1 3 2 Radiologist Review Prior to Viewing CAD Marks The radiologist first reviews the Philips mammograms without viewing the SecondLook Digital CAD marks following her or his existing procedures of clinical practice The radiologist will make an initial determination if a work up is indicated for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation Radiologist Review with CAD Marks The radiologist turns on and views the SecondLook Digital CAD marks with the softcopy review workstation after determining whether or not a work up is indicated from her or his initial review of the patient mammograms The radiologist will take a SecondLook at the mammograms corresponding to any CAD marks From this re evaluation of the mammograms the radiologist determines if any additional work up is required If there are no CAD marks no re evaluation of the mammograms is necessary Work up decisions are not based solely upon the CAD marks All work up decisions are based upon review of the mammograms supporting clinical information and CAD marks by the radiologist Areas of concern marked by SecondLook Digital include suspicious clusters of microcalcifications sp
9. d from below FB e Effectiveness and safety have not been established using magnification and spot compression views When these views are analyzed by the system any resulting CAD marks should not be used by the radiologist in evaluating the patient e CAD analysis is performed on images both individually and at a case based level Consequently the number of CAD marks on a specific image can vary depending upon the number of images included in the study when CAD analysis is performed Precautions Installation and Maintenance A e This product contains no independently user serviceable parts To prevent damage to the system do not attempt to install or repair the SecondLook system Only trained personnel are qualified to install or repair the system For service training contact the local Philips Representative or iCAD Inc at 1 937 431 1464 option 1 e Disconnect power cord before moving or servicing 2 5 Adverse Effects SecondLook may increase your false positive rates for both screening and diagnostic mammography Increased false positives may lead to unnecessary additional imaging radiation exposure biopsy patient anxiety etc 2 6 Clinical Studies Refer to the SecondLook Analog for further details regarding the testing studies used to support the safety and effectiveness of the original approval of the SecondLook analog device for use with digitized film screen mammograms DTM094 iCAD Inc Page 10 of 23 APPROVED 05 21
10. esigned nor intended to prompt to o interval change s between mammographic exams asymmetry between the left and right breast tubular density solitary dilated duct skin thickening or nipple retraction Oo oO DTM094 iCAD Inc Page 8 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A Warnings System Operation A e Do not use SecondLook if you suspect any electrical component is defective or inoperable e Do not place liquids on or near SecondLook If a liquid is accidentally spilled on electrical components immediately turn off the system to prevent any potential electrical shock Contact iCAD Inc at 1 937 431 1464 option 1 for further instructions e Ensure that the system is connected to a properly wired and grounded power receptacle e Ensure that the voltage and current requirements are within system specifications to avoid bodily injury from electrical shock or fire hazard Warnings Installation and Maintenance A e EMC Warning This SecondLook system has been tested and found to comply with IEC 60950 1 EN 55022 and EN 55024 This system generates uses and can radiate radio frequency energy and if not installed and used in accordance with our installation instructions may cause or be subject to harmful interference with other devices in the vicinity If the SecondLook system appears to cause or be subject to harmful interference try the following steps to cor
11. evereesseeis 7 se bvawtn ie dudes eesvewtamecesdszar svacdoubededeeduseamecducesdessdesadsateoetsers 7 INDICATIONS FOR eelere 7 BRIEF DEVICE EIERE Dee ee 7 WARNINGS Getreide cette 8 TC 10 EES 10 Eleng 10 DETAILED DEVICE DESCRIPTION Beetaciiessencusesacscud visti Eeer 11 CONFORMANCE EE 15 HOW SUPPLIED yee a E E E E e EE pecs 15 bd eve anA E EE A EEA 16 RADIOLOGIST REVIEW PRIOR TO VIEWING CAD Make 16 RADIOLOGIST REVIEW WITH CAD MR emsgetie eegene 16 sebecdne tie E 17 TRAINING INSTRUCTIONS iinr in Ee 17 SAMPLE CASE oaee a tae AE AA Eeer 18 T E E Zeg 21 ORE PR E EE E AA EA E E E E E A E 22 iCAD Inc Page 5 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A This page intentionally left blank DTM094 iCAD Inc Page 6 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A This manual describes the SecondLook Digital Computer Aided Detection CAD system and provides training to radiologists using the SecondLook Digital system for breast cancer detection e Section 2 provides SecondLook device labeling e Section 3 describes how a radiologist should use SecondLook Digital e Section 4 provides a sample case to familiarize the radiologist with SecondLook Digital e Section 5 provides a summary of the radiologist use of SecondLook Digital e Section 6 provides a list of clinical references 2 1 Indications for Use The SecondLook Computer A
12. findings 3 cm circumscribed mass with partially obscured borders in the right breast at 10 o clock shown to be a cyst on ultrasound Linear distribution of pleomorphic calcifications in the right breast at 2 o clock posteriorly Pathology Ductal carcinoma in situ arrows show location DTM094 iCAD Inc Page 20 of 23 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A The radiologist uses the SecondLook Digital CAD marks with mammography according to the following steps 1 2 3 The radiologist first reviews the Philips mammograms without viewing the CAD marks following her or his existing procedures of clinical practice The radiologist will make an initial determination if a work up is indicated for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation The radiologist turns on and views the CAD marks with the softcopy review workstation after determining whether or not a work up is indicated from her or his initial review of the patient mammograms The radiologist will take a SecondLook at the mammograms corresponding to any CAD marks From this re evaluation of the mammograms the radiologist determines if any additional work up is required If there are no CAD marks no re evaluation of the mammograms is necessary Work up decisions are not based solely upon the CAD marks All work up decisions are based upon review of the mammograms supportin
13. g clinical information and CAD marks by the radiologist DTM094 iCAD Inc Page 21 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A 1 Bird RE Wallace TW Yankaskas BC Analysis of Cancers Missed at Screening Mammography Radiology 184 pp 613 617 1992 2 Sickles EA Auditing Your Practice RSNA Categorical Course in Breast Imaging 1995 pp 81 91 3 Harvey JA Fajardo LL Innis CA Previous Mammograms in Patients with Impalpable Breast Carcinoma Retrospective vs Blinded Interpretation AJR 161 pp 1167 1172 1993 4 Martin JE Moskowitz M Milbrath JR Breast Cancer Missed by Mammography AJR 132 pp 737 739 1979 5 Schmidt RA Nishikawa RM Digital Screening Mammography PPO Updates 8 7 pp 1 16 1994 6 Thurfjell EL Lernevall KA Taube AAS Benefit of Independent Double Reading in a Population based Mammography Screening Program Radiology 191 pp 241 244 1994 7 Economic Impact Analysis of Regulations Under the Mammography Quality Standards Act of 1992 U S Food and Drug Administration and Eastern Research Group Inc Task Order No 1 Contract No 223 94 8031 October 7 1997 8 Quality Determinants of Mammography Clinical Practice Guideline Number 13 Agency for Health Care Policy and Research Publication No 95 0632 October 1994 9 Warren Burhenne LJ Wood SA D Orsi CJ et al Potential contribution of computer aided detect
14. gist with the procedures for using the SecondLook Digital CAD marks The case review procedures are emphasized Therefore the training is accomplished by following the case presentation in Section 4 2 of this manual without requiring use of the softcopy review station For the example case in the manual the procedures for using SecondLook Digital CAD marks are demonstrated to the radiologist with the following steps 1 The first page will provide the case history and printed versions of the Philips mammograms without CAD marks During clinical use the radiologist would first review the mammograms without viewing the CAD marks following her or his existing procedures of clinical practice The radiologist would make an initial determination if a work up were indicated for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation 2 The second page contains printed versions of the mammograms with CAD marks turned on During clinical use the radiologist would take a SecondLook at the mammograms corresponding to any CAD marks From this re evaluation of the mammograms the radiologist would determine if any additional work up was required If there were no CAD marks no re evaluation of the mammograms would be necessary Work up decisions are not based solely upon the CAD marks All work up decisions are based upon review of the mammograms supporting clinical information and CAD marks by the radiologist
15. iculated and non spiculated masses architectural distortions and focal asymmetric densities Below is the recommended case review process with SecondLook Digital 1 Review patient history and evaluate Philips mammograms prior to turning on and viewing CAD marks with softcopy review workstation 2 Make initial interpretation 3 Turn on and view CAD marks with softcopy review workstation and identify potential areas of concern 4 Review mammograms re evaluating areas of concern highlighted by CAD marks with softcopy review workstation 5 Render decision It is very important to remember that it is the radiologist who makes the final decision about a case When a radiologist decides to work up a case the CAD marks must not change the decision however the CAD marks can identify locations for further work up that were initially undetected by the radiologist Note If the CAD algorithm fails to process the review workstation will notify the user about the failure Depending upon the review workstation configuration this notification may differ For example a large X may be displayed across the image when the user turns the CAD on DTM094 iCAD Inc Page 16 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A 4 1 Training Instructions One sample case demonstrates the use of SecondLook Digital for the radiologist prior to clinical use This case is intended to familiarize the radiolo
16. ided Detection CAD system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from Philips full field digital mammography FFDM systems to bring them to the attention of the radiologist after an initial reading has been completed Thus the system prompts the radiologist to areas on Philips mammograms for second review only 2 2 Brief Device Description SecondLook is a mammographic CAD system that prompts radiologists to areas on Philips mammograms for a second review only The CAD algorithm version 7 2 includes image processing feature computations and pattern recognition technology to detect regions of interest The algorithm was originally trained on digitized film screen mammograms and intended to more specifically identify potential breast lesions appearing as clusters of microcalcifications and or masses The CAD system was adapted to run on Philips images but the CAD algorithm design remained unchanged and was not otherwise retrained on the Philips mammograms DTM094 iCAD Inc Page 7 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A For hardcopy reading the SecondLook output can be presented on a paper printout showing the CAD marks within the mammogram How to Use the CAD SecondLook with the Philips FFDM system is intended to be used by a radiologist as follows The radiologist must always first perform a full conventional read
17. ion to the sensitivity of screening mammography Radiology 2000 215 554 562 10 Freer TW Ulissey MJ Screening mammography with computer aided detection prospective study of 12 860 patients in a community breast center Radiology 2001 220 781 786 11 Gur D Sumkin JH Rockette HE et al Changes in breast cancer detection and mammography recall rates after the introduction of a computer aided detection system JNCI 2004 96 3 185 190 12 Birdwell RL Bandodkar P Ikeda DM Computer aided detection with screening mammography in a university hospital setting Radiology 2005 236 451 457 13 Cupples TE Cunningham JE Reynolds JC Impact of computer aided detection in a regional screening mammography program AJR 2005 185 944 950 14 Khoo LAL Taylor P Given Wilson RM Computer aided detection in the United Kingdom National Breast Screening Programme prospective study Radiology 2005 237 444 449 15 Morton MJ Whaley DH Brandt KR et al Screening mammograms interpretation with computer aided detection prospective evaluation Radiology 2006 239 375 383 16 Dean JC Ilvento CC Improved cancer detection using computer aided detection with diagnostic and screening mammography prospective study of 104 cancers AJR 2006 187 20 28 DTM094 iCAD Inc Page 22 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A 17 Ko JM Nicholas MJ Mendel JB Slanetz PJ Prospective assessment
18. mputer aided diagnosis CAD in mammography Comparison of mammographic diagnosis with and without use of CAD European Journal of Radiology 2004 51 66 72 26 Hukkinen K Vehmas T Pamilo M Kivisaari L Effect of computer aided detection on mammographic performance experimental study on readers with different levels of experience Acta Radiologica 2006 47 257 263 27 Taplin SH Rutter CM Lehman CD Testing the effect of computer assisted detection on interpretive performance in screening mammography AJR 2006 187 1475 1482 28 Brem RF Baum J Kaplan S Improvement in Sensitivity of Screening Mammography with Computer Aided Detection A Multiinstitutional Trial AUR 2003 181 687 693 DTM094 iCAD Inc Page 23 of 23 APPROVED 05 21 2010
19. rect the problem o Reorient or relocate the SecondLook system or the interface device o Increase the separation between the SecondLook system and the interfering device o Plug the SecondLook system into an outlet on a different circuit from the interfering device o Contact iCAD Inc at 1 937 431 1464 option 1 for further instructions e Temperature and Humidity Warning SecondLook system operations must be performed within the following temperature and humidity ranges o Temperature 50 95 Fahrenheit 10 35 Celsius o Humidity 20 80 DTM094 iCAD Inc Page 9 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A 2 4 Precautions A Precautions System Operation e To prevent damage to the system maintain equipment in a well ventilated air conditioned environment e Effectiveness and safety in patients with breast implants has not been established for views that include the implant When implant displaced views are analyzed by the system any resulting CAD marks should not be used by the radiologist in evaluating the patient e Effectiveness and safety has been established using all full breast mammographic views including craniocaudal CC mediolateral oblique MLO exaggerated craniocaudal XCC exaggerated craniocaudal rotated laterally XCCL exaggerated craniocaudal rotated medially KCCM mediolateral ML lateromedial LM lateromedial oblique LMO an
20. rther analysis of detected areas is accomplished by clustering individual microcalcifications and region growing densities Clusters include 3 or more individual microcalcifications that are each no more than 4 1 millimeters apart Figure 3 depicts portions of three different mammography images showing how the SecondLook system would highlight microcalcifications clusters in these examples These examples use CAD marks that are rectangular and correspond to the approximate size of the microcalcifications Region growing determines the shape of potential densities as shown in Figure 4 DTM094 iCAD Inc Page 13 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A Figure 3 CalcMarks Highlighting Microcalcifications Clusters with a The minimum number of calcifications b The extent of the CalcMark enclosing all calcifications considered as part of the cluster c Overlapping CalcMarks are distinctly highlighted even when clusters are close to each other After clustering for microcalcifications analysis and region growing for density analysis clinically relevant and mathematical features are then computed to describe each detected cluster of microcalcifications and density For example the variability in size and shape of the calcifications in a cluster are good features to describe clusters of microcalcifications These features are used by microcalcifications and density classifiers which are
21. specifically designed to select the areas most likely to have features that may be seen with cancer Further analysis uses the context of all areas selected for the patient For example there is a maximum total number of SecondLook CAD marks each 4 image case can include Simultaneous analysis of all areas of concern detected in the patient allows the locations most likely to be cancer to be highlighted by the CAD marks DTM094 iCAD Inc Page 14 of 23 APPROVED 05 21 2010 SecondLook Digital for Philips DR Labeling and User Manual Rev A Figure 4 Region Growing to Determine Shape of Density 2 8 Conformance to Standards Refer to the SecondLook Digital Service Manual for the CE Declaration of Conformity DTB060 2 9 How Supplied The SecondLook system includes the following components Computer The SecondLook Digital CAD server ships without anti virus software However anti virus software can be installed without voiding the warranty if iCAD s installation procedure is followed This installation procedure is available at www icadmed com or through an authorized re seller of iCAD products iCAD has tested anti virus software products from McAfee Symantec and Norton and no issues have been reported The current list of approved anti virus software is available at www icadmed com On a semi annual basis iCAD tests patches to the Microsoft Operating System OS for compatibility with the SecondLook Digital CAD system The
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