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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
Original Applicant
GENERAL MEDICAL MERATE S.P.A.
25 via partigiani
seriate (bg),  IT 24068
Original 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 (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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