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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K897000
Device Name IMAGEMASTER-101(TM)
Applicant
Columbia Scientific, Inc.
8940-K Old Annapolis Rd.
Columbia,  MD  21045
Applicant Contact D STOCKHAM
Correspondent
Columbia Scientific, Inc.
8940-K Old Annapolis Rd.
Columbia,  MD  21045
Correspondent Contact D STOCKHAM
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/18/1989
Decision Date 03/23/1990
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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