FDA 510(k) Application Details - K250831

Device Classification Name	More FDA Info for this Device
510(K) Number	K250831
Device Name	Annalise Enterprise
Applicant	Annalise-AI 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	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2025
Decision Date	04/23/2025
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