FDA 510(k), K200755, Caption Guidance
FDA 510(k), K200755, Caption Guidance
510(K) Number: K200755
Device Name: Caption Guidance
Manufacturer: Caption Health
Device Classification Name: Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Regulation Number:
Classification Product Code: QJU
Date Received: 03/23/2020
Decision Date: 04/16/2020
Regulation Medical Specialty: Radiology
238 pages (1,080 of 1,318 pages fully redacted)
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