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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Automatic, Radiographic
510(k) Number K050092
Device Name R605 FACS COLLIMETER
Applicant
Omega Medical Imaging, Inc.
675 Hickman Cir.
Sanford,  FL  32771
Applicant Contact JAMES A PRINCEHOM
Correspondent
Omega Medical Imaging, Inc.
675 Hickman Cir.
Sanford,  FL  32771
Correspondent Contact JAMES A PRINCEHOM
Regulation Number892.1610
Classification Product Code
IZW  
Date Received01/14/2005
Decision Date 01/31/2005
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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