FDA 510(k) Application Details - K242334

Device Classification Name	More FDA Info for this Device
510(K) Number	K242334
Device Name	Ezra Flash
Applicant	Ezra AI, Inc. 419 Park Ave S, Suite 600 New York, NY 10016 US Other 510(k) Applications for this Company
Contact	David Girard Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2024
Decision Date	01/02/2025
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