磁気共見鳥画像診離置承認基準の制定について 薬事法 (昭和35軸韓ー
Contents
1.2. JIS T 14971 JIS T 0601 1 1 43 1 4
3. JIS T 0601 1 1 21 22 23 JIS Z 4951 26 JIS T 0601 1 1 56 3 a JIS T 0601 1 1 42
4. 2 3
5. 9 JIS T 14971 JIS T 0601 1 1 21 22 23 24 25 28 45
6. JIS T 060 1 1 6 JIS T 0601 1 1 1 1 6
7. 10 JIS T 0601 1 1 1 1
8. 49 101 JIS T 0601 1 1 56 11 d JIS T 14971 JIS T 14971 JIS T 0601 1 1 25 42 43 JIS T 0601 1 1 6 8 2 j 2
9. 3 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 2 2 NEMA MS2 Determination of two dimensional geometric distortion in diagnostic magnetic resonance images 3 NEMA MS3 Determination of image uniformity in diagnostic magmetic resonance images 4
10. 5 6 JIS T 0601 1 1 44 4 56 11 d
11. gt i L 2 40 Na
12. JIS T 0601 1 1 6 8 3 a JIS Z 4951 6 8 2 6 8 3 JIS T 0601 1 1 49 52 JIS T 14971 2 3 4
13. JIS T 14971 8 K
14. JIS T 0601 1 2 1 2 36 201 JIS T 0601 1 2 1 2 36 202 JIS T 0601 1 1 14 15 16 17 18 19 20 52 56 57 58 59 1 3
15. 5 6 7
16. 17 2 16 0216002 i 4 i i NE A 17 3 31 0331012 1 2 5 7 16 298 2 121 MR 122 MR 123 MR
17. 4 i 5
18. 6 7 8 9
19. oO JIS T 0601 1 1 6 3 g JIS Z 4951 6 8 2 ee 36 51 JIS Z 4951 51 101 51 103 51 1
20. 3 4 5
21. JIS 16 169 JIS T 14971 JIS T 0601 1 1 7 JIS Z 4951 JIS T 14971
22. JIS T 0601 1 2 1 2 6 JIS Z 4951 6 17 3 10 0310003 JIS T 14971 16 17 2 16 0216002 2 1 2
23. 4 5 1
24. 2 3 4 5
25. 6 16 169 16 169 JIS T 14971 16 169 JIS T 14971
26. 7 2 3
27. 8 1 2
28. JIS T 14971 FDA 510 k Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices 1 SNR NEMA MSI Determination of signal to noise ratio SNR in diagnostic magnetic resonance imageSs 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 Tesonance imaging MR FDA 510 k Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices 1 SNR NEMA MSl Determination of signal to noise ratio SNR in diagnostic magnetic resonance images 3dB
29. 2 3 4 CRT
30. 2 3 10
31. 1 4 1 2 3 15
32. 2 3
33. 0401052 1 7 4 1 Pi NS nN EH ET oe 0 EN 35 145 3 14 1 19 2 1 14 9 19 2 5 I VD ul rl 1
34. 11 c JIS T 0601 1 1 10 2 2 49 JIS T 0601 1 2 1 2 36 202 JIS Z 4951 45
35. 124 MR 125 MR 126 MR 127 MR 128 MR 129 MN 130 MR 131 WR 132 MR 17 4 1 1 2 121 132 Z 4951 3
36. 17 2 16 0216002 1 smo Bl 3 14 96 2 14 RA 19 OE te 5
37. 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 4 5 11
38. 05 JIS Z 4951 6 8 2 gg 51 102 51 104 JIS T 0601 1 1 29 2 X CRT 5 6 7
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