Mri Division,Beijing Wandong Medical Technology Co., Ltd. FDA Approvals

0 new drug approvals and 2 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
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System510(k)Jul 1, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 1, 2022
i_Space 1.5T Superconducting Magnetic Resonance Imaging System510(k)Jan 29, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 29, 2021