の通知 [ PDF 768 kB ]
Contents
1. 3 16 169 RR OR 0 JIS2. 2
3. 5 JIS T 0601 1 2 1 2 36 202 1 6
4. v 5 a 6
5. JIST0601 1 1 43 3 JIST0601 1 1 6 8 2 j 10
6. RF RF MR FDA 510 k Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices 1 SNR NEMA MS1 Determination of signal tornoise ratio SNR in diagnostic magnetic resonance images 3dB JIS Z 4951
7. 7 8 9
8. JIS T 0601 1 1 43 JIS T 0601 1 1 43 1 2
9. 7 8 1 2
10. 8 2
11. 2 3 4
12. 2 3 4 5
13. 3 es NM 4
14. 2 3
15. 11 2 3
16. JIS T 14971 JIS T 14971 6 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 7
17. 16 169 JIS T 14971 5 16 169
18. 3 N 4
19. 3 JIS T 0601 1 1 15
20. JIST 0601 1 1 56 3 a 5 1 4 2
21. 5 6 JIS T 0601 1 1 44 4 JIS T 14971
22. JIS T 0601 1 1 13 14 16 17 19 20 7 13 JIS T 0601 1 1 21 23
23. NN MR JIST 0601 1 1 19 JIS Z 4951 51 103 9 JIS T 14971 JIST0601 1 1 21 22 23 JIST0601 1 2
24. 1 SGS 1 17 112 372 MR 16 169 1
25. 23 2 1 17 471 MR 17 3 31 0331012 6 2 IVD
26. JIS T 0601 1 1 6 16 2 JIS T 0601 1 2 1
27. 36 51 JIS Z 4951 51 103 51 105 4 5 JIST0601 1 1 6 8 3 a JIS Z 4951 6 8 2 6
28. 1 2 36 202 1 JIS T 0601 1 1 44 3 JIS T 14971 2
29. 2 3 4 v
30. 2 6 JIS Z 4951 6 17 3 10 0310003 JIS T 14971 17 2 16 0216002 2 1 2
31. 10
32. Cy 1025002 17 10 25 _ 3 1 1025001 17 10 25 3 35 145 2 3 2 1 4 1 3 17 8 12 0812003 2
33. T 14971 JIS JIS T 0601 1 1 7 JIS Z 4951 7 JIS T 14971 4
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