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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K931315
Device Name KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR
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 Number892.1900
Classification Product Code
IXW  
Date Received03/15/1993
Decision Date 12/14/1993
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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