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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, Stationary
510(k) Number K920558
Device Name KONICA DIRECT DIGITIZER KD-1000
Applicant
Konica Corp.
9 E. 37th St.
New York,  NY  10016
Applicant Contact RUSSELL D MUNVES
Correspondent
Konica Corp.
9 E. 37th St.
New York,  NY  10016
Correspondent Contact RUSSELL D MUNVES
Regulation Number892.1680
Classification Product Code
KPR  
Date Received12/13/1991
Decision Date 03/06/1992
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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