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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 K172793
Device Name SKR 3000
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  
Subsequent Product Code
LLZ  
Date Received09/15/2017
Decision Date 10/12/2017
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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