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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K203346
Device Name OEC 3D
Applicant
GE OEC Medical Systems, Inc.
384 N Wright Brothers Drive
Salt Lake City,  UT  84116
Applicant Contact Kenny M. Bello
Correspondent
GE OEC Medical Systems, Inc.
384 N Wright Brothers Drive
Salt Lake City,  UT  84116
Correspondent Contact Rachel Schandel
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Codes
JAA   OWB  
Date Received11/13/2020
Decision Date 03/05/2021
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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