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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K200621
Device Name Caption Interpretation Automated Ejection Fraction Software
Caption Health
2000 Sierra Point Pkwy
Brisbane,  CA  94005
Applicant Contact Sam Surette
Caption Health
2000 Sierra Point Pkwy
Brisbane,  CA  94005
Correspondent Contact Sam Surette
Regulation Number892.2050
Classification Product Code
Date Received03/09/2020
Decision Date 07/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls