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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 K223267
Device Name SKR 3000
Konica Minolta, INC.
1 Sakura-machi
Hino-shi,  JP 191-8511
Applicant Contact Tsutomu Fukui
Konica Minolta Healthcare Americas, Inc.
411 Newark Pompton Turnpike
Wayne,  NJ  07470
Correspondent Contact Jan Maniscalco
Regulation Number892.1680
Classification Product Code
Subsequent Product Code
Date Received10/24/2022
Decision Date 11/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No