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FDA 510(k) Application Details - K193271
Device Classification Name
More FDA Info for this Device
510(K) Number
K193271
Device Name
uAI EasyTriage-Rib
Applicant
Shanghai United Imaging Intelligence Co., Ltd.
No. 199, Huanke Road
Shanghai 201210 CN
Other 510(k) Applications for this Company
Contact
Zhao Xiaojing
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QFM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/26/2019
Decision Date
01/15/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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