FDA 510(k) Application Details - K250685

Device Classification Name	More FDA Info for this Device
510(K) Number	K250685
Device Name	Methinks NCCT Stroke
Applicant	Methinks Software S.L. Pier 01, Plaτa Pau Vila 1, Office 2D2 Barcelona 08039 ES Other 510(k) Applications for this Company
Contact	Claudia Carbonell Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2025
Decision Date	06/16/2025
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