FDA 510(k) Application Details - K231384

Device Classification Name	More FDA Info for this Device
510(K) Number	K231384
Device Name	Annalise Enterprise CTB Triage Trauma
Applicant	Annalise-AI Pty Ltd. Level P, 24 Campbell St. Sydney 2000 AU Other 510(k) Applications for this Company
Contact	Haylee Bosshard Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2023
Decision Date	09/22/2023
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