Polarean, Inc. 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
XENOVIEW 3.0T Chest Coil510(k)Nov 19, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Nov 19, 2024
XENOVIEW 3.0T Chest Coil510(k)Jun 29, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jun 29, 2023
XENOVIEW 3.0T Chest Coil510(k)Dec 23, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 23, 2022
Xenoview VDP510(k)Dec 23, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 23, 2022