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FDA 510(k) Application Details - K173965
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K173965
Device Name
System, Image Processing, Radiological
Applicant
Inteware Co. Ltd.
4F., No.93, Xinzheng 5th St.
Minxiong Township, Chiayi Country 62145 CN
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Contact
Wayne Tsai
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
12/29/2017
Decision Date
10/26/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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