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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 K213908
Device Name SKR 3000
Applicant
Konica Minolta, INC.
1 Sakura-machi
Hino-shi,  JP 191-8511
Applicant Contact Tsutomu Fukui
Correspondent
Konica Minolta Healthcare Americas, Inc.
411 Newark-Pompton Turnpike
Wayne,  NJ  07470
Correspondent Contact Jan Maniscalco
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LLZ  
Date Received12/14/2021
Decision Date 01/31/2022
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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