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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 K051521
Device Name REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION
Applicant
Konica Minolta Medical & Graphic, Inc.
319 Akeno Obata-Cho
Watarai-Gun, Mie-Ken,  JP 519-05
Applicant Contact SHINICHI YAMANAKA
Correspondent
Konica Minolta Medical & Graphic, Inc.
319 Akeno Obata-Cho
Watarai-Gun, Mie-Ken,  JP 519-05
Correspondent Contact SHINICHI YAMANAKA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/08/2005
Decision Date 06/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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