FDA 510(k) Application Details - K222268

Device Classification Name	More FDA Info for this Device
510(K) Number	K222268
Device Name	Annalise Enterprise CXR Triage Trauma
Applicant	Annalise-AI Pty Ltd Level P, 24 Campbell St Sydney 2000 AU Other 510(k) Applications for this Company
Contact	Minta Chen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2022
Decision Date	03/28/2023
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