FDA 510(k) Application Details - K212915

Device Classification Name	More FDA Info for this Device
510(K) Number	K212915
Device Name	MVision AI Segmentation
Applicant	MVision AI C/O Terkko Health Hub, Haartmaninkatu 4 Helsinki 00290 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	09/13/2021
Decision Date	05/03/2022
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