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| A guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components | |||
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| 분류 | Molecular imaging, Guidance | 조회 | 2530 |
| 발행년도 | 2014 | 등록일 | 2015-10-02 |
| 출처 | FDA (바로가기) | ||
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This guide outlines for a manufacturer, a format for the presentation of initial and supplemental reports on diagnostic x-ray systems and their major components which are subject to the Performance Standard 21 CFR 1020.30,1020.31, and 1020.32.
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