Polarean, Inc.

Research Triangle Park, NC, US · 4 510(k) clearances

Total clearances

2022-12-23 → 2024-11-19

Last 12 months

Product codes

Most recent

2024-11-19

Trend

Clearance cadence by quarter

Portfolio

Code	Device name	Class	Specialty	Clearances	Most recent
MOS	Coil, Magnetic Resonance, Specialty	Class II	Radiology	3	2024-11-19
LLZ	System, Image Processing, Radiological	Class II	Radiology	1	2022-12-23

Filings

Date	K-number	Device	Code	Class	Specialty
2024-11-19	K243316	XENOVIEW 3.0T Chest Coil	MOS	Class II	Radiology
2023-06-29	K231647	XENOVIEW 3.0T Chest Coil	MOS	Class II	Radiology
2022-12-23	K223071	Xenoview VDP	LLZ	Class II	Radiology
2022-12-23	K212239	XENOVIEW 3.0T Chest Coil	MOS	Class II	Radiology