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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K902005
Device Name MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE
Applicant
Omega Medical Imaging, Inc.
671 Hickman Cir.
Sanford,  FL  32771
Applicant Contact ROBERT C LINDQUIST
Correspondent
Omega Medical Imaging, Inc.
671 Hickman Cir.
Sanford,  FL  32771
Correspondent Contact ROBERT C LINDQUIST
Regulation Number892.1650
Classification Product Code
JAA  
Date Received05/04/1990
Decision Date 09/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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