FDA 510(k) Application Details - K221762

Device Classification Name	More FDA Info for this Device
510(K) Number	K221762
Device Name	BoneMRI v1.4
Applicant	MRlguidance B.V. Gildstraat 91a Utrecht 3572 NL Other 510(k) Applications for this Company
Contact	Marijn van Stralen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2022
Decision Date	11/16/2022
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