FDA 510(k) Application Details - K233030

Device Classification Name	More FDA Info for this Device
510(K) Number	K233030
Device Name	BoneMRI
Applicant	MRIguidance B.V Maliesingel 23 Utrecht 3581 BG NL Other 510(k) Applications for this Company
Contact	David Sparks 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	09/25/2023
Decision Date	03/01/2024
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