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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 K062647
Device Name E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
Applicant
Omega Medical Imaging, Inc.
675 Hickman Cir.
Sanford,  FL  32771
Applicant Contact JAMES A PRINCEHORN
Correspondent
Omega Medical Imaging, Inc.
675 Hickman Cir.
Sanford,  FL  32771
Correspondent Contact JAMES A PRINCEHORN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received09/06/2006
Decision Date 10/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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