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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K051418
Device Name DIRECT DIGITIZER REGIUS MODEL 370
Applicant
Konica Minolta Medical & Graphic, Inc.
319 Akeno
Obata-Cho, Watarai-Gun
Mie-Ken,  JP 519-05
Applicant Contact SHINICHI MAMANAKA
Correspondent
Konica Minolta Medical & Graphic, Inc.
319 Akeno
Obata-Cho, Watarai-Gun
Mie-Ken,  JP 519-05
Correspondent Contact SHINICHI MAMANAKA
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/01/2005
Decision Date 07/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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