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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 K210747
Device Name Caption Interpretation Automated Ejection Fraction Software
Applicant
Caption Health
2000 Sierra Point Pkwy.
Brisbane,  CA  94005
Applicant Contact Sam Surette
Correspondent
Manatt, Phelps, & Phillips, Llp
1 Embarcadero Center
30th Floor
San Francisco,  CA  94111
Correspondent Contact Savannah Hari
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/12/2021
Decision Date 01/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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