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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 K192819
Device Name OEC Elite
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 Kenny M Bello
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Codes
JAA   OWB  
Date Received10/01/2019
Decision Date 11/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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