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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image Acquisition And/Or Optimization Guided By Artificial Intelligence
510(k) Number K201992
Device Name Caption Guidance
Applicant
Caption Health
2000 Sierra Point Pkwy.
Brisbane,  CA  94005
Applicant Contact Sam Surette
Correspondent
Caption Health
2000 Sierra Point Pkwy.
Brisbane,  CA  94005
Correspondent Contact Sam Surette
Classification Product Code
QJU  
Date Received07/17/2020
Decision Date 09/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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