FDA 510(k) Application Details - K250754

Device Classification Name	More FDA Info for this Device
510(K) Number	K250754
Device Name	cmAngio« (V1.6)
Applicant	CureMetrix, Inc. 402 West Broadway Suite # 400 San Diego, CA 92101 US Other 510(k) Applications for this Company
Contact	Kevin Harris 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	03/12/2025
Decision Date	04/10/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review