厚生労船医薬食品局長 磁気共耳鳥画像診暇置承認基準の制定について
Contents
1. 4 OT2. 3 JIS T 0601 1 i 1
3. JJS T 0601 1 1 1 1
4. 16 169 JIS T 14971 2
5. 1 5 Es 2
6. JIS JIS T 0601 1 1 7 JIS Z 4951 JIS T 14971
7. 1 3
8. 17 2 16 0216002 4 17 3 31 0331012
9. 1 2 JIS T 0601 1 1 49 52
10. EDA 510 k Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices 1 SNR NEMA MS1 Determination of signal to hoise ratio SNR in diagnostic magnetic resonance 1mages 2 2 NEMA MS2 Determination of two dimenstonal geometric distortion in diagnostic magnetic resonance 1mages 3 NEMA MS3 Determination of image uniformity in diagnostic magnetic resonance 1mages 4 NEMA MS5 Determination of slice thickness in diagnostic magnetic resonance 1maging 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
11. JTS T 14971 2 JTS T 0601 1 1 25 42 43 52 56 57 5
12. gt JIS T 0601 1 1 44 4 56 11 d JIS T 14971 1 2
13. 17 2 16 0216002 2 1 2
14. 4 JIS T 0601 1 1 56 3 a 5 JIS T 0601 1
15. 5 6 8
16. 8 9 10
17. 1 J 3 16 169
18. 4 5
19. Ei 6 7
20. 6 JIS T 0601 1 1 1 1 0 6 JIS T 0601 1 2 1 2 6 JIS Z 4951 6 17 3 10 0310003 JIS T 14971 16
21. 1 2 36 201 6 hs JIS T 0601 1 2 1 2 36 202 7
22. 1 2 5 7 2 16 298 121 3 MR 122 MR 123 124 3 MR MR 125 3 MR 126 3 MR H MR EE EE E EE BR MR MR MR
23. JIS T 0601 1 1 7 13 14 15 16 17 18 19 ib 20 52 56 57 58 59 13 JIS T 0601 1
24. 1 21 22 23 24 25 28 2 3 JIS Z 4951 26
25. 169 JIS T 14971 JIS T 14971 6 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 1mages 2 2 NEMA MS2 Determination of two dimensiona geometric distor
26. 9 TS T 14971 JIS T 0601 1 1 21 22 23 24 25 28 45 56 11 c JIS T 0601 1 1 10 2 2 49 JIS T 0601 1 2 1 2
27. 36 202 ED JIS Z 4951 45 49 101 JIS T 0601 1 1 56 11 d 1 JIS T 14971
28. 4 16 169 1 JIS T 14971 5 16
29. 6 3
30. 6 8 2 gg 4 CRT JIS T 0601 1 1 29 2 CRT 5
31. JIS T 0601 1 1 6 8 3 a JIS Z 4951 8 6 8 2 6 8 3 6 a 7 8
32. JIS T 14971 2 3 j 4 5 JIS T 0601 1 2
33. 3 4 5
34. NRN MR EE MR 17 4 1 1 2 121 132 2 Z 4951 3 4 5 H
35. 0216002 1 2 3 14 96 2 14 1 19 2 1
36. JIS T 0601 1 1 6 3 g 11 JIS Z 4951 6 8 2 ee 36 51 2 JIS Z 4951
37. 0401052 1 7 4 1 35 145 14 1 19 2 1 14 9 19 2 5 VD 1 1 17 2 16
38. 1 42 1 4 5 2 3
39. 51 101 51 102 51 103 51 104 51 105 3 JIS Z 4951
40. 4971 JIS T 0601 1 1 43 1 2 3
41. 9 3 JIS T 0601 1 1 6 8 2 1 0 2
42. tion in diagnostic magnetic resonance 1mages 3 NEMA MS3 Determination of 1image uniformity in diagnostic magmetic resonance 1mageS 4 NEMA MS5 Determination of slice thickness in diagnostic magnetic resonance 1maglng 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 magmetic resonance images 3dB 7 JIS T 1
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