# Polarean, Inc.

- Location (FDA's records): Research Triangle Park, NC
- FDA decisions: 4 (2022–2024): 4 510(k) clearances
- Product codes: MOS (3), LLZ (1)
- 510(k) review time since 2016: median 56 days, against 69 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Invivo Corporation: 1 (https://510kreport.com/company/invivo)

## Its most-cited devices
- K212239: XENOVIEW 3.0T Chest Coil (2022), cited by 1
- K231647: XENOVIEW 3.0T Chest Coil (2023), cited by 1

## Recent decisions
- K243316: XENOVIEW 3.0T Chest Coil (Nov 19, 2024)
- K231647: XENOVIEW 3.0T Chest Coil (Jun 29, 2023)
- K223071: Xenoview VDP (Dec 23, 2022)
- K212239: XENOVIEW 3.0T Chest Coil (Dec 23, 2022)

Source page: https://510kreport.com/company/polarean