Mriguidance B.V. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
BoneMRI510(k)Aug 21, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 21, 2026
BoneMRI510(k)Mar 1, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 1, 2024
BoneMRI v1.6510(k)Feb 22, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Feb 22, 2023
BoneMRI510(k)Dec 22, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 22, 2021