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