Page 1 Page 2 Page 3 Page 4 第一章 般的要求 駄要件 適合の方法
Contents
1. 22. JIS T 14971 JIS T 0601 1 1 43 1 3
3. 3 16 169 4
4. 4
5. 2 3
6. JIS JIS T 14971 JES T 0601 1 1 7 JIS Z 4951 JIS T 14971
7. 4 5
8. 3 4 1 3
9. JIS T 0601 1 49 52 JIS T 14971 _ 2 3
10. tp 1 5 2
11. 3 JTS T 0601 1 1
12. 4 5 6 7
13. 6 8 2 ee 36 51 2 JIS Z 4951 51 101 51 102
14. 4 5 JIS T 0601 1 1 6 3 g 11 JIS Z 4951
15. 5 6
16. JIS T 0601 1 1 42 1 4 2 3
17. 17 2 16 0216002 2 1 2
18. 49 101 JIS T 0601 1 1 56 11 d JIS T 14971 JIS T 14971 JIS T 0601 1 1 25 42 43 52 56 57 59 3 JIS T 0601 1
19. 17 2 16 0216002 4 17 5 23 17 3 31 0331012 EL 1 2 5 7 16 298 2 121
20. 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 17 18 19 20 52 56 57 58 59
21. 29 2 CRT 5 JIS T 0601 1 1 6 8 3 a JIS Z 4951 6 6 8 2 6 8 3 6
22. 9 JIS 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
23. 10 JIS T 0601 1 1 1
24. 7 8 9
25. FDA 510 k Guidance for the Submission Of Premariket Notifications for Magnetic Resonance Diagnostic Devices 1 SNR NEMA MS1 Determination of signal to noise ratio SNR in diagnostic magnetic Tresonance 1mages 2 2 NEMA MS2 Determination of two dimensiona 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 thickmess in diagnostic magnetic resonance imaging MR FDA 510 k Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devioes 1 SNR NEMA MS1 Determination of signal to noise ratio SNR in diagnostic magnetic resonance images 3dB 3
26. 2 3 14 96 2 14 1 19 2 1
27. 7 8 1 2 2
28. JTS T 0601 1 21 22 23 24 25 28 2 JIS Z 4951 26 JIS T 0601 1 1 56 3 a 5
29. 51 103 51 104 51 105 3 JIS Z 4951 6 8 2 gg 4 CRT JIS T 0601 1 1
30. 16 169 JIS T 14971 5 16 169
31. 6 JIS T 0601 1 1 1 1 6 JIS T 0601 1 2 1 2 6 JIS Z 4951 6 17 3 10 0310003 JIS T 14971 16
32. 1 6 8 2 10 2
33. 3 4 5 H 1 16 169
34. 0401052 1 7 4 1 35 145 14 1 19 2 1 14 9 19 2 5 1 VD 1 17 2 16 0216002 S 1
35. 2 36 202 JIS Z 4951 45 2
36. MR 122 MR 123 MR 124 MR 125 MR 126 MR 127 MR 128 MR 129 MR 130 MR 131 MR 132 MR 17 4 1 1 2 121 132 2 Z 4951
37. 6 JIS T 0601 1 1 44 4 56 11 d IS T 14971 8
38. JIS T 14971 JIS T 14971 6 i FDA 510 k Guidance for the Submission Of Premarket Notifications For Magnetic Resonance Diagnostic Devices 1 SNR NEMA MS1 Determination of signal1 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 1mage uniformity in diagnostic magnetic resonance 1mages 4 NEMA MS5 Determination of slice thickness in
39. 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 SNE in diagnostic magmetic resonance images 3dB 7 2
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