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FDA 510(k) Application Details - K230039
Device Classification Name
More FDA Info for this Device
510(K) Number
K230039
Device Name
uOmnispace
Applicant
Shanghai United Imaging Healthcare Co., Ltd
No. 2258 Chengbei Rd., Jiading District
Jiading Industrial District
Shanghai 201807 CN
Other 510(k) Applications for this Company
Contact
Gao Xin
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2023
Decision Date
07/20/2023
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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