XENOVIEW
xenon Xe 129 hyperpolarized
POLAREAN, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010132318 | 3010132318 | POLAREAN, INC. | 1 | N | 2026-01-01 | 2500 Meridian Pkwy, #175 Durham NC US 27713 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 315940 | 1325375191 | K243316 | XENOVIEW 3.0T Chest Coil | MOS | 2024-11-19 |
| 315940 | 1763514563 | K231647 | XENOVIEW 3.0T Chest Coil | MOS | 2023-06-29 |
| 315940 | 1729205454 | K223071 | Xenoview VDP | LLZ | 2022-12-23 |
| 315940 | 1915842170 | K212239 | XENOVIEW 3.0T Chest Coil | MOS | 2022-12-23 |
Product Codes Associated With Registrations#
NDC#
PMN#
XENOVIEW 3.0T Chest Coil
Polarean, Inc.
XENOVIEW 3.0T Chest Coil
Polarean, Inc.
XENOVIEW 3.0T Chest Coil
Polarean, Inc.
Xenoview VDP
Polarean, Inc.
Applications#
GUDID#
XENOVIEW VDP - XENOVIEW VDP is an image analysis platform that quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarized 129-Xe ventilation MR image and accompanying proton chest MR image. The software provides a user-friendly interface and simple workflow that helps guide the user through the image analysis process, including the loading of images, registration of the anatomical image sets to the HP 129Xe image sets, segmentation of the lung, and automated classification of normalized ventilation distribution into multiple intensity levels via analysis of hyperpolarized 129Xe signal intensity within the segmented lung volume. The results of the image analysis are output as medical images of the classified ventilation, a summary report, and data files containing quantitative statistical analysis results.
2026-05-07
XENOVIEW 3.0T Chest Coil-GE Premier - The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 129Xe frequency on a 3.0T MRI magnetic field in order to image 129Xe nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 129Xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs.The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive, water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a “fixed matching and tuning device” (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.
2025-12-19
HPX Polarization Measurement Station - The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 129 signal. The HPX Polarization Measurement Station accomplishes the following: Ensures that the amount of XENOVIEW® in the XENOVIEW® Dose Delivery Bag is sufficient for measurement; Calculates the Dose Equivalent (DE) value prior to administration to a patient; Stores a XENOVIEW® Dose Delivery Bag filled with XENOVIEW® in a static magnetic field.
2025-10-13
XENOVIEW Dose Delivery Bag, Carton of 50, 1,000 mL - The XENOVIEW® Dose Delivery Bag is a single-use disposable drug container, for use with the HPX Hyperpolarization System. The XENOVIEW® Dose Delivery Bag is used to collect the dispensed XENOVIEW® (xenon Xe 129 hyperpolarized) from the HPX Hyperpolarizer for patient administration. The bag is equipped with a mouthpiece for easy administration to the patient. The 47471-100 XENOVIEW® Dose Delivery Bag Carton comes packaged with 50 each of 1,000 mL Dose Delivery Bag assemblies, as well as 55 individual bag labels.
2025-10-13
XENOVIEW Dose Delivery Bag, Carton of 50, 750 mL - The XENOVIEW® Dose Delivery Bag is a single-use disposable drug container, for use with the HPX Hyperpolarization System. The XENOVIEW® Dose Delivery Bag is used to collect the dispensed XENOVIEW® (xenon Xe 129 hyperpolarized) from the HPX Hyperpolarizer for patient administration. The bag is equipped with a mouthpiece for easy administration to the patient. The 47471-075 XENOVIEW® Dose Delivery Bag Carton comes packaged with 50 each of 750 mL Dose Delivery Bag assemblies, as well as 55 individual bag labels.
2025-10-13
XENOVIEW Dose Delivery Bag, Carton of 50, 500 mL - The XENOVIEW® Dose Delivery Bag is a single-use disposable drug container, for use with the HPX Hyperpolarization System. The XENOVIEW® Dose Delivery Bag is used to collect the dispensed XENOVIEW® (xenon Xe 129 hyperpolarized) from the HPX Hyperpolarizer for patient administration. The bag is equipped with a mouthpiece for easy administration to the patient. The 47471-050 XENOVIEW® Dose Delivery Bag Carton comes packaged with 50 each of 500 mL Dose Delivery Bag assemblies, as well as 55 individual bag labels.
2025-10-13
XENOVIEW Dose Delivery Bag, Carton of 50, 300 mL - The XENOVIEW® Dose Delivery Bag is a single-use disposable drug container, for use with the HPX Hyperpolarization System. The XENOVIEW® Dose Delivery Bag is used to collect the dispensed XENOVIEW® (xenon Xe 129 hyperpolarized) from the HPX Hyperpolarizer for patient administration. The bag is equipped with a mouthpiece for easy administration to the patient. The 47471-030 XENOVIEW® Dose Delivery Bag Carton comes packaged with 50 each of 300 mL Dose Delivery Bag assemblies, as well as 55 individual bag labels.
2025-10-13
XENOVIEW 3.0T Chest Coil - The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 129Xe frequency on a 3.0T MRI magnetic field in order to image 129Xe nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 129Xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs.The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive, water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a “fixed matching and tuning device” (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.
2025-09-23
XENOVIEW 3.0T Chest Coil - The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 129Xe frequency on a 3.0T MRI magnetic field in order to image 129Xe nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 129Xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs.The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive, water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a “fixed matching and tuning device” (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.
2025-09-23
HPX Hyperpolarizer - The HPX Hyperpolarizer is the device used to hyperpolarize the Xenon Xe 129 Gas Blend for the production of XENOVIEW™. It consists of a laser optical pumping system and a cryogenic xenon condenser system.With the use of the HPX Gas Handling Manifold, the Xenon Xe 129 Gas Blend is delivered to the HPX Hyperpolarizer where it undergoes spin exchange optical pumping (SEOP) process, which produces XENOVIEW™.
2023-05-04
XENOVIEW Dose Delivery Bag - The XENOVIEW™ Dose Delivery Bag is used to collect the dispensed XENOVIEW™ (xenon Xe 129 hyperpolarized) from the HPX Hyperpolarizer for patient administration. The bag is equipped with a clamp to secure XENOVIEW™ inside, and a mouthpiece for the patient to inhale the gas. XENOVIEW™ Dose Delivery Bags come packaged with 50 one-liter dose delivery bag assemblies, as well as 55 individual bag labels. The XENOVIEW™ Dose Delivery Bag is a single-dose disposable drug container, for use with the HPX Hyperpolarization System.
2023-05-04
HPX Polarization Measurement Station - The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 129 signal. The HPX Polarization Measurement Station accomplishes the following: Ensures that the amount of XENOVIEW™ in the XENOVIEW™ Dose Delivery Bag is sufficient for measurement; Calculates the Dose Equivalent (DE) value prior to administration to a patient; Stores a XENOVIEW™ Dose Delivery Bag filled with XENOVIEW™ in a static magnetic field.
2023-05-04
HPX Gas Handling Manifold - The HPX Gas Handling Manifold is an ultra-high purity (UHP) gas pressure regulation and purification system that allows for two Xenon Xe 129 Gas Blend cylinders, one NF-grade UHP nitrogen cylinder and one industrial nitrogen cylinder to be connected to the HPX Hyperpolarizer.
2023-05-04