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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, fluoroscopic, image-intensified
510(k) Number K936136
Device Name UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE
Original Applicant
GE DEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city,  UT  84116
Original Contact robert odell
Regulation Number892.1650
Classification Product Code
JAA  
Date Received12/22/1993
Decision Date 01/25/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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