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Polarean, Inc.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest FDA decision2024-11-19
TypeNumberDevice NameCodeDateActions
510(k) K243316 XENOVIEW 3.0T Chest CoilMOS2024-11-19 View
510(k) K231647 XENOVIEW 3.0T Chest CoilMOS2023-06-29 View
510(k) K212239 XENOVIEW 3.0T Chest CoilMOS2022-12-23 View
510(k) K223071 Xenoview VDPLLZ2022-12-23 View