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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
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