FDA-COMPUTER ASSIST › Guidance for Industry and Food and Drug Administration Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions

FDA-COMPUTER ASSIST - 2022 EDITION - CURRENT
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Guidance for Industry and Food and Drug Administration Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions


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Document Number

1697

Revision Level

2022 EDITION

Status

Current

Publication Date

Sept. 28, 2022

Page Count

29 pages