FDA 510(k) Application Details - K183285

Device Classification Name	More FDA Info for this Device
510(K) Number	K183285
Device Name	cmTriage
Applicant	CureMetrix, Inc 9404 Genesee Ave., Suite 330 La Jolla, CA 92037 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	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2018
Decision Date	03/08/2019
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