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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
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