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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,  DK 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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