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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
Applicant
NRT-NORDISK RONTGEN TEKNIK A/S
BIRKEGAARDSVEJ 16
HASSELAGER,  DK 8361
Applicant Contact JAN MALLING
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
1279 QUARRY LANE, SUITE A
PLEASANTON,  CA  94566
Correspondent Contact HEINZ-JORG STENEBERG
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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