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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 K183204
Device Name Bone VCAR (BVCAR)
Applicant
GE Medical Systems SCS
283 rue de la Miniere
Buc,  FR 78530
Applicant Contact Elizabeth Matthew
Correspondent
GE Medical Systems SCS
283 rue de la Miniere
Buc,  FR 78530
Correspondent Contact Elizabeth Matthew
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
LLZ  
Date Received11/19/2018
Decision Date 04/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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