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)