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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 K041605
Device Name PRECISION RXI ANALOG X-RAY SYSTEM
Applicant
GENERAL MEDICAL MERATE S.P.A.
25 via partigiani
seriate (bg),  IT 24068
Applicant Contact kevin walls
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received06/15/2004
Decision Date 06/30/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
statement statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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