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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 K222676
Device Name Ceevra Reveal 3
Applicant
Ceevra, Inc.
149 New Montgomery St, 4th Fl.
San Francisco,  CA  94105
Applicant Contact Ken Koster
Correspondent
Ceevra, Inc.
149 New Montgomery St, 4th Fl.
San Francisco,  CA  94105
Correspondent Contact Ken Koster
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/06/2022
Decision Date 04/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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