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FDA 510(k) Application Details - K231353
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K231353
Device Name
System, Image Processing, Radiological
Applicant
ArteryFlow Technology Co., Ltd.
459 Qianmo Road, Suite C1-501, Binjiang District
Hangzhou 310051 CN
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Contact
Jianping Xiang
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
05/10/2023
Decision Date
09/14/2023
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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