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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
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
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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