FDA 510(k), K200621, Caption Interpretation Automated Ejection Fraction Software

510(K) Number: K200621
Device Name: Caption Interpretation Automated Ejection Fraction Software
Manufacturer: Caption Health
Device Classification Name: Automated Radiological Image Processing Software
Regulation Number: 892.2050
Classification Product Code: QIH
Date Received: 03/09/2020
Decision Date: 07/22/2020
Regulation Medical Specialty: Radiology

1,131 pages (839 of 1,970 fully redacted)