Data / Medical devices / United States / Polarean, Inc.
Polarean, Inc.: FDA-registered device maker in Durham, NC, United States, 4 510(k) clearances
Polarean, Inc. is registered with the FDA (registration 3010132318) in Durham, NC, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010132318
- Address
- 2500 Meridian Pkwy, #175, Durham, NC, United States, 27713
- Owner or operator
- Polarean, Inc. (10087679)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 27, 2023
- Registered through
- 2026
- Brand names listed
- XENOVIEW 3T Chest Coil, Xenoview VDP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2024 | K243316 | XENOVIEW 3.0T Chest Coil | MOS | Substantially Equivalent | Polarean, Inc. | accessdata.fda.gov |
| June 29, 2023 | K231647 | XENOVIEW 3.0T Chest Coil | MOS | Substantially Equivalent | Polarean, Inc. | accessdata.fda.gov |
| December 23, 2022 | K223071 | Xenoview VDP | LLZ | Substantially Equivalent | Polarean, Inc. | accessdata.fda.gov |
| December 23, 2022 | K212239 | XENOVIEW 3.0T Chest Coil | MOS | Substantially Equivalent | Polarean, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, Image Processing, Radiological
Updated November 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.