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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 K071181
Device Name DIRECT DIGITIZER, REGIUS MODEL 110
Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
140 EAST 45TH ST., 25TH FLOOR
TWO GRAND CENTRAL TOWER
NEW YORK,  NY  10017
Applicant Contact RUSSEL MUNVES
Correspondent
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
140 EAST 45TH ST., 25TH FLOOR
TWO GRAND CENTRAL TOWER
NEW YORK,  NY  10017
Correspondent Contact RUSSEL MUNVES
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/30/2007
Decision Date 05/30/2007
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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