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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K212685
Device Name KONICAMINOLTA DI-X1
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 Tpke.
Wayne,  NJ  07470
Correspondent Contact Jan Maniscalco
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/24/2021
Decision Date 09/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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