磁気共鳴画像診断装置承認基準の制定について (平成17年4月1日) (薬
Contents
1.2. 1
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4. Co 3 Ei Ri 3 1 1 1 1
5. 1
6. JIS T 0601 1 2 1 2 36 201 JIS T 0601 1 2 1 2 36 202 JIS T 0601 1 1 7 13 14 15 16
7. 12
8. 1 UIS T 0601 1 1 6 3 g 11
9. _ JIS T 0601 1 1 49 52 JIS T 14971 4
10. JIS T 0601 1 2 JIS 1 ks 7 JIS Z 4951
11. AD 14 96 2 14 1 19 2 1
12. 2 _ 3 15
13. JIS T 0601 1 1 1 JIS T 14971 JIS T 0601 1 1 21 22 23 24 1 Ri
14. 5 15 T 0601 1 JIS T 0601 1 1 42 14
15. 6 16 169 JIS T 14971 5 PDA 510 K Guidanoo TA for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices 1 SNR NEMA MS1 Determination of signal to noise ratio SNR in diagnostic magnetic resonance ImageS 2 2 NEMA MS2 Determination of two dimensional geometric distortion in diagnostic magnetic resonance Images 3 NEMA MS3 Determination of Image uniformity in diagnostic magnetic resonance Images 4 NEMA MS5 Determination of slice thickness in diagnostic magnetic resonance imaging MR FDA 510 k Guidance for the Submission Of Premarket Notifications for Magnetic Res
16. 51 105 JIS Z 4951 6 0 2 gg UIS T 0601 1 1 29 2 X CRT 5
17. 45 56 11 c JIS T 0601 1 1 10 2 2 49 JIS T 0601 1 2 1 2 36 202 JIS Z 4951 45 49 101
18. Ri JIS Z 4951 ee UIS Z 4951 51 101 102 103 51 104
19. 17 2 16 0216002 a ek 17 3 31 0331012 1 2 5 7 3 16 298 2 121 MR 122 MR 123 MR
20. UIS T 0601 1 1 6 8 3 a JIS Z 4951 8 6 8 2 6 8 3 6
21. 10 hi 56 57 FDA 510 k Guidance
22. ln dR NN iA AN 3 JIS T 14971 Ri 0
23. 4 A 5 a 1 16 169 lt a JIS T 14971
24. 0 O 17 4 1 0401052 a A 14 1 19 2 1 14 9 19 2 5 IVD NR OO 17 2 16 0216002 1
25. 5 i 13
26. JIS Z 4951 6 17 3 10 0310003 A JIS T 14971 16 17 2 16 0216002 2 1
27. JIS T 14971 JIS T 14971 2 ji Ri JIS T 0601 1 1 25 42 43 52 2 59 jj JIS T 0601 1 1 6 8 2 j
28. 9 3 0 RI 2 SS dy ll 9
29. 4 16 169 JIS T 14971 5
30. 44 4 56 11 d JIS T 14971 8
31. 1 JIS T 0601 1 1 6 JIS T 0601 1 1 1 1 6 JIS T 0601 1 2 1 2 6
32. 17 18 20 52 57 58 59 19 56 JIS T 0601 1 1 21 22 23 24 25 28 3 JIS Z 4951 26 4
33. 124 MR 125 MR 126 MR 127 MR 128 MR 129 MR 130 MR 131 MR 132 MR 17 4 1 1 2 2 121 132 2 Z 4951 3
34. 4
35. for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices Determination of signal to noise ratio SNR in diagnostic magnetic resonance ImageS 2 2 NEMA MS2 Determination of two dimensional geometric distortion In diagnostic magnetic resonance ImageS 3 NEMA MS3 Determination of Image uniformity in diagnostic magnetic resonance Images 4 NEMA MS5 Determination of slice thickness in diagnostic magnetic resonance Imaging MR FDA 510 k Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices 1 SNR NEMA MS1 Determination of signal to noise ratio SNR in diagnostic magnetic resonance images 3dB
36. onance Diagnostic Devices 1 SNR NEMA MS1 Determination of signal to noise ratio SNR in diagnostic magnetic resonance images 3dB 7 Pe
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