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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 K243933
Device Name Ceevra Reveal 3+
Applicant
Ceevra, Inc.
149 New Montgomery St.
4th Floor
San Francisco,  CA  94105
Applicant Contact Ken Koster
Correspondent
Ceevra, Inc.
149 New Montgomery St.
4th Floor
San Francisco,  CA  94105
Correspondent Contact Ken Koster
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/20/2024
Decision Date 03/04/2025
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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