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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K243446
Device Name 3DXR
Applicant
GE Medical Systems SCS
283 Rue De La Miniere
Buc,  FR 78530
Applicant Contact Ning WEN
Correspondent
GE Medical Systems SCS
283 Rue De La Miniere
Buc,  FR 78530
Correspondent Contact Ning WEN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
QIH  
Date Received11/06/2024
Decision Date 02/25/2025
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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