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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 K210066
Device Name ImagePilot
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  27529
Correspondent Contact Jan Maniscalco
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/11/2021
Decision Date 05/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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