Medical Device Manufacturer · US , Research Triangle Park , NC

Polarean, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2022
4
Total
4
Cleared
0
Denied

FDA 510(k) cleared devices by Polarean, Inc. Radiology ✕

4 devices
1-4 of 4
Cleared Nov 19, 2024
XENOVIEW 3.0T Chest Coil
K243316 · MOS
Radiology · 28d
Cleared Jun 29, 2023
XENOVIEW 3.0T Chest Coil
K231647 · MOS
Radiology · 24d
Cleared Dec 23, 2022
XENOVIEW 3.0T Chest Coil
K212239 · MOS
Radiology · 522d
Cleared Dec 23, 2022
Xenoview VDP
K223071 · LLZ
Radiology · 84d
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