Polarean, Inc.
United StatesFDA applicant, unverified FDA FEI 3010132318
- Devices
- 17
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Polarean, Inc. makes
Polarean, Inc. manufactures systems and accessories for xenon hyperpolarization in lung MRI imaging, including hyperpolarizers, dose delivery bags, and specialized chest coils designed for 3.0T MRI scanners. Their portfolio includes components for gas handling, polarization measurement stations, and mouthpieces tailored for patient administration of xenon gas. These devices are used to enhance MRI contrast in lung imaging studies by enabling hyperpolarized xenon gas visualization.
The company’s products are classified under FDA categories Class II and Class N, with regulatory submissions including 510(k) clearances and UDI listings. These devices are intended for use in the United States, where they are subject to FDA oversight. The portfolio is not authorized outside the US without additional regulatory pathways.
Catalogue
Search and filter all 17 devicesCompany details
- FDA FEI number
- 3010132318
- DUNS number
- 078629330
- Address
- 2500 Meridian Pkwy, #175, Durham, NC, 27713
Frequently asked questions
How many devices does Polarean, Inc. have in the registry?
The registry currently lists 17 devices for Polarean, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Polarean, Inc.'s devices?
Among its 17 most recently registered devices, Polarean, Inc. has devices listed in FDA 510(k) (4 devices) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Polarean, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Polarean, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Polarean, Inc. in the registry?
The most recently registered devices listed for Polarean, Inc. include XENOVIEW 3.0T Chest Coil Rev B, XENOVIEW Dose Delivery Bag, Carton of 50, 750 mL Rev A, XENOVIEW Dose Delivery Bag, Carton of 50, 300 mL Rev A and XENOVIEW 3.0T Chest Coil-GE Premier Rev A.