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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K240369
Device Name CAC (gated) Algorithm
Applicant
Bunkerhill Health
436 Bryant St.
San Francisco,  CA  94107
Applicant Contact Nishith Khandwala
Correspondent
Bunkerhill Health
436 Bryant St.
San Francisco,  CA  94107
Correspondent Contact Nitya Narayanan
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/07/2024
Decision Date 09/27/2024
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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