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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K202335
Device Name Ambra ProViewer
Applicant
Dicom Grid, Inc, dba Ambra Health
199 Water St., 34th Floor
New York,  NY  10038
Applicant Contact Patrice Nedelec
Correspondent
Accelerated Device Approval Services
6800 S.W. 40th Street, Ste. 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/17/2020
Decision Date 09/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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