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FDA 510(k) Application Details - K210066
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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