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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 K162504
Device Name SKR 3000
Applicant
Konica Minolta, Inc.
1 Sakura-Machi
Hino-Shi,  JP 191-8511
Applicant Contact TSUTOMU FUKUO
Correspondent
Storch Amini & Munves PC
140 E. 45th St.
25th Floor
New York,  NY  10017
Correspondent Contact RUSSELL D. MUNVES
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LLZ  
Date Received09/07/2016
Decision Date 10/03/2016
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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