FDA 510(k) Application Details - K243933

Device Classification Name	More FDA Info for this Device
510(K) Number	K243933
Device Name	Ceevra Reveal 3+
Applicant	Ceevra, Inc. 149 New Montgomery St. 4th Floor San Francisco, CA 94105 US Other 510(k) Applications for this Company
Contact	Ken Koster 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	12/20/2024
Decision Date	03/04/2025
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