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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 K042386
Device Name DIRECT DIGITIZER, REGIUS MODEL 190
Applicant
Konica Minolta Medical & Graphic, Inc.
Progress Section
319 Akeno, Obata-Cho
Watarai-Gun; Mie-Ken,  JP 519-05
Applicant Contact SHINICHI YAMANAKA
Correspondent
Konica Minolta Medical & Graphic, Inc.
Progress Section
319 Akeno, Obata-Cho
Watarai-Gun; Mie-Ken,  JP 519-05
Correspondent Contact SHINICHI YAMANAKA
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/02/2004
Decision Date 12/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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