FDA 510(k), K201992, Caption Guidance
FDA 510(k), K201992, Caption Guidance
510(K) Number: K201992
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: 07/17/2020
Decision Date: 09/18/2020
Regulation Medical Specialty: Radiology
Total pages: 262
Fully redacted pages: 170
Content pages: 92
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