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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K223152
Device Name Vision 2, EVARVision, TrackVision 2, HeartVision 2
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 Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
OWB  
Date Received10/06/2022
Decision Date 11/22/2022
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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