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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 K931313
Device Name KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR
Applicant
Konica Medical Corp.
C/O Storch Amini & Munves, P.C
1090 Vermont Ave. NW, Suite 800
Washington,  DC  20005
Applicant Contact RUSSELL D MUNVES
Correspondent
Konica Medical Corp.
C/O Storch Amini & Munves, P.C
1090 Vermont Ave. NW, Suite 800
Washington,  DC  20005
Correspondent Contact RUSSELL D MUNVES
Regulation Number892.1900
Classification Product Code
IXW  
Date Received03/15/1993
Decision Date 09/07/1993
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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