FDA 510(k) Application Details - K210066

Device Classification Name System, Image Processing, Radiological

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510(K) Number K210066
Device Name System, Image Processing, Radiological
Applicant Konica Minolta, Inc.
1 Sakura-machi
Hino-shi 191-8511 JP
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Contact Tsutomu Fukui
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 01/11/2021
Decision Date 05/06/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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