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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 K241300
Device Name ViewPoint 6
Applicant
Ge Healthcare GmbH
Oskar-Schlemmer-Straße 11
München,  DE 80807
Applicant Contact Brandon O'Shea
Correspondent
Ge Healthcare
9900 Innovation Dr.
Wauwatosa,  WI  53225
Correspondent Contact Brandon O'Shea
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/09/2024
Decision Date 07/02/2024
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
Recalls CDRH Recalls
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