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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 K033486
Device Name GE PRECISION MPI
Original Applicant
NRT-NORDISK RONTGEN TEKNIK A/S
birkegaardsvej 16
hasselager,  DA 8361
Original Contact jan malling
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received11/04/2003
Decision Date 11/19/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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