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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 K093688
Device Name CANON, MODEL URS-50RF
Applicant
VIRTUAL IMAGING, INC.
8726 FERRARA CT
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
VIRTUAL IMAGING, INC.
8726 FERRARA CT
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received11/30/2009
Decision Date 02/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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