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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 K230223
Device Name iCAC Device
Applicant
Bunkerhill, Inc.
428 El Verano Ave.
Palo Alto,  CA  94306
Applicant Contact Nishith Khandwala
Correspondent
Hogan Lovells Llp
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/26/2023
Decision Date 04/25/2023
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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