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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K193225
Device Name KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography
Applicant
Konica Minolta Healthcare Americas, Inc.
2217 Us Hwy. 70 E.
Garner,  NC  27529
Applicant Contact Jan Maniscalco
Correspondent
Konica Minolta Healthcare Americas, Inc.
2217 Us Hwy. 70 E.
Garner,  NC  27529
Correspondent Contact Jan Maniscalco
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received11/22/2019
Decision Date 01/15/2020
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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