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FDA 510(k) Application Details - K223621
Device Classification Name
More FDA Info for this Device
510(K) Number
K223621
Device Name
DeepXray
Applicant
Alpha Intelligence Manifolds, Inc.
2F, No. 170, Zhonghe Rd., Zhonghe District
New Taipei City 235068 TW
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Contact
Qingzong Tseng
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2022
Decision Date
09/08/2023
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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