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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K251769
Device Name RevealAI-Lung
Applicant
Precision Medical Ventures, Inc. Dba Revealdx
1800 Westlake Ave. N.
Suite 104
Seattle,  WA  98109
Applicant Contact Michael Calhoun
Correspondent
Hogan Lovells U.S. Lpp
1800 Westlake Ave. N., Suite 104
Seattle,  WA  98109
Correspondent Contact Michael Calhoun
Regulation Number892.2060
Classification Product Code
POK  
Date Received06/10/2025
Decision Date 01/30/2026
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		 No
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