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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 K082243
Device Name PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
Applicant
GENERAL MEDICAL MERATE S.P.A.
5401 S. COTTONWOOD COURT
GREENWOOD VILLAGE,  CO  80121
Applicant Contact Kevin Walls
Correspondent
GENERAL MEDICAL MERATE S.P.A.
5401 S. COTTONWOOD COURT
GREENWOOD VILLAGE,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received08/07/2008
Decision Date 11/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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