別添（PDF:480KB）
Contents
1. CABG2. 1 Adantis SR Pro b
3. 40MHz
4. G8 OL NR
5. Y
6. O 3
7. 1 10mL
8. 3 5mm lt gt 9
9. 1 5cm X NO 0 5cm
10. PMP 3 AP 1 6
11. 7 a W MM 2 21600BZY00111000 2 21400BZY00183000 2 a 2 20800BZY00037000 Te CL i Lab 219ABBZX00239000 iLab 219ABBZX00238000 3 3mL 10mL
12. X
13. 4 6 ALARA 1 30 in situ 30 in situ R
14. 1 3 6 2
15. Y 3 6
16. 7 8 9 1 0 064 r 3 E E E
17. 3 O G5
18. EH H FDA Information or Manufactu Diagnostic Ultrasound Syst E FDA rers Seeking Market Clearance of ems and Transducers 1997 9 30 1997 09 30 MI TD IVUS in situ in situ
19. H E 1 i FDA
20. i 0 014 0 36mm 1 63mm E 4 H J
21. EE 7 2 1 65 941 22 6 2 3 4 2 907 3 I 3
22. E 0
23. 27 2 6 0120 177 779 044 287 7660 1 N 2 6 6
24. PRE 9 Q0
25. E dN X 3 EMC
26. 8 0 2 2 2 1 2 ll D 3 3
27. 4 5 B 1 6 2 7 3 8 X 4 9 5 lt gt 10N 10N 0 014 0 36mm
28. 0 Q 5 6mm E 8 i dae
29. SM 1 X lt CABG X
30. 6 7 3 7 M PraFawf n a Cu 1MPa MHz n a MPa MHz mW n a pi a 2 12dB cm Ms Hz Ipi MPa MD W Cm 1 2 1
31. oii X X 2
32. 1 1 4 1 1 4 1 14 11 03 5322 3559 5320 4510 5320 4514 34 460 34 491 1 7 7 4 3 8 0 1 7 0 1
33. PTCA 1 DAR RA LC ER 1 0
34. MINI NO TI I EC 60601 2 37 2001 MI TIS Scan 0 267 0 006 P MPa 1 21 P mW 0 033 P Z 1 Z Zs 2 Z 1 em 0 073 da Z MHz 35 8 35 8 A x 0 080 cm y 0 080 9 0 058 P_ 7680 OE P Ipi MPa 1 32 d py 1 MI W cm 56 5 wt 3 Q 45
35. CABG PTCA
36. 1 1 4 X 3cm 3mL 10mL
37. Other Ispra 3 Isppas MI mW cm W cm 0 267 3 80 56 5 P MPa 1 21 W mW 0 033 0 033 MHz 35 8 35 8 35 8 Z 0 073 0 073 Fm lt X cm 0 057 Y cm 0 059 PD s 0 058 0 058 PRF Hz 7680 7680 Re Az cm 0 335 Elev cm 0 053 28 7 23 4 17 9 16 0 6 7 3 7 MI MI P fc n a Loras
38. 15cm 10mL 3mL 3mL 2 5
39. TI 2 1 7 3 3 1 0331021 SC 107AF 2010 7 7 7 2009 4 23 6 21200BZY00484000 ul 51 70289004 Atlantis SR Pro
40. 2 3 ET 1 5 27
41. 1 1 14 11 03 3343 9300 1 14 11 03 5322 3711 Boston Scientifc Corporation 3
42. 21200BZY00484000 0 6 15 24cm 0 gt a 6 ke 1 0 064 0 63mm 0 014 0 36mm 5 SS ab 15cm 2 6
43. mW cm Ia W cm NB W mW E MHz Z cm X Zsp xy 6dB cm a PD us PRF Hz EDS AA a cm IEC 60601 2 37 2001 MA EC Particular requirements for Galaxy Galaxy M2 ClearView Ultra
44. LeXD 0 069 EZ in situ E im MHz Z in situ situ E 0 08cm 4 for Manufacturers Seek Ultrasound Systems and Transducers 1997 9 30 Atlantis SR Pro2 40 MHz B MDU5 iLab FDA Information ing Market Clearance of Diagnostic Fetal Imaging amp
45. 60 105cm B
46. iLab MD5 MDU5 Galaxy Galaxy2 iLab MD4 ClearView Ultra MP EC 60601 2 37 2001 MI he safety of ultrasonic medical diagnostic and monitormg equipment 4 28 7 23 4 3 Hf 17 9 16 0
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