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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 K013054
Device Name KONICA DIRECT DIGITIZER REGIUS MODEL 350
Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
2970 ISHIKAWA-CHO
HACHIOJI-SHI TOKYO,  JP 192-8505
Applicant Contact KOJI KUBO
Correspondent
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
2970 ISHIKAWA-CHO
HACHIOJI-SHI TOKYO,  JP 192-8505
Correspondent Contact KOJI KUBO
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/11/2001
Decision Date 03/01/2002
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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