FDA 510(k) Application Details - K241490

Device Classification Name	More FDA Info for this Device
510(K) Number	K241490
Device Name	Contour+ (MVision AI Segmentation)
Applicant	MVision AI Oy Paciuksenkatu 29 6th Floor Helsinki 00270 FI Other 510(k) Applications for this Company
Contact	Kalpana Jha Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2024
Decision Date	10/18/2024
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