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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 K243779
Device Name Bunkerhill Abdominal Aortic Quantification (AAQ)
Applicant
Bunkerhill Health
436 Bryant St.
San Francisco,  CA  94107
Applicant Contact Nishith Khandwala
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact John Smith
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/09/2024
Decision Date 07/01/2025
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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