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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 K233669
Device Name OEC 3D
Applicant
GE OEC Medical Systems, Inc.
384 Wright Brothers Drive
Salt Lake City,  UT  84116
Applicant Contact Shawn Quigley
Correspondent
GE OEC Medical Systems, Inc.
384 Wright Brothers Drive
Salt Lake City,  UT  84116
Correspondent Contact Shawn Quigley
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Codes
JAA   OWB  
Date Received11/15/2023
Decision Date 03/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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