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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 Ln., 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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