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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Intensifying, Radiographic
510(k) Number K963913
Device Name MD100 & MM150
Applicant
Konica Medical Corp.
The Chrysler Bldg.
405 Lexington Ave.
New York,  NY  10174
Applicant Contact RUSSELL D MUNVES
Correspondent
Konica Medical Corp.
The Chrysler Bldg.
405 Lexington Ave.
New York,  NY  10174
Correspondent Contact RUSSELL D MUNVES
Regulation Number892.1960
Classification Product Code
EAM  
Date Received09/30/1996
Decision Date 10/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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