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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K974355
Device Name INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
Original Applicant
GE DEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city,  UT  84116
Original Contact ted l parrot
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received11/19/1997
Decision Date 02/17/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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