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FDA 510(k) Application Details - K223240
Device Classification Name
More FDA Info for this Device
510(K) Number
K223240
Device Name
Annalise Enterprise CTB Triage Trauma
Applicant
Annalise-AI Pty Ltd
Level 21, 60 Margaret St.
Sydney 2000 AU
Other 510(k) Applications for this Company
Contact
Haylee Bosshard
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/2022
Decision Date
04/03/2023
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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