Polarean, Inc.

Medical device manufacturer in Durham, NC.

4510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K243316XENOVIEW 3.0T Chest CoilMOS · Special 11/19/2024SE
K231647XENOVIEW 3.0T Chest CoilMOS · Special 06/29/2023SE
K223071Xenoview VDPLLZ · Traditional 12/23/2022SE
K212239XENOVIEW 3.0T Chest CoilMOS · Traditional 12/23/2022SE