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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 K191645
Device Name SKR 4000
Applicant
Konica Minolta, Inc.
1 Sakura-machi
Hino-shi,  JP 191-8511
Applicant Contact Tsutomu Fukui
Correspondent
Storch Amini PC
140 East 45th Street
25th Floor
New York,  NY  10017
Correspondent Contact Russell D. Munves
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/19/2019
Decision Date 08/16/2019
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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