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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 K261595
Device Name Ceevra Reveal 4
Applicant
Ceevra, Inc.
465 California St.
7th Floor
San Francisco,  CA  94104
Applicant Contact Ken Koster
Correspondent
Ceevra, Inc.
465 California St.
7th Floor
San Francisco,  CA  94104
Correspondent Contact Ken Koster
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/14/2026
Decision Date 08/25/2026
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		 Yes
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