FDA 510(k) Application Details - K212116

Device Classification Name	More FDA Info for this Device
510(K) Number	K212116
Device Name	VBrain-OAR
Applicant	Vysioneer Inc. 33 Rogers. St., # 308 Cambridge, MA 02142 US Other 510(k) Applications for this Company
Contact	Vicki Lin 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	07/07/2021
Decision Date	10/12/2021
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