| Primary Device ID | 00850045949075 |
| NIH Device Record Key | bda3931e-b20d-495b-8830-dd64bbaf4491 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XENOVIEW 3.0T Chest Coil-GE Premier |
| Version Model Number | Rev A |
| Catalog Number | 44315-04 |
| Company DUNS | 078629330 |
| Company Name | Polarean, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00850045949075 - XENOVIEW 3.0T Chest Coil-GE Premier | 2025-12-29The 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. |
| 00850045949075 - XENOVIEW 3.0T Chest Coil-GE Premier | 2025-12-29 The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned |
| 00850045949044 - XENOVIEW 3.0T Chest Coil | 2025-10-01 The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned |
| 00850045949051 - XENOVIEW 3.0T Chest Coil | 2025-10-01 The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned |
| 00850045949006 - HPX Hyperpolarizer | 2023-05-12 The HPX Hyperpolarizer is the device used to hyperpolarize the Xenon Xe 129 Gas Blend for the production of XENOVIEW™. It cons |
| 00850045949013 - XENOVIEW Dose Delivery Bag | 2023-05-12 The XENOVIEW™ Dose Delivery Bag is used to collect the dispensed XENOVIEW™ (xenon Xe 129 hyperpolarized) from the HPX Hyperp |
| 00850045949020 - HPX Polarization Measurement Station | 2023-05-12 The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 1 |
| 00850045949037 - HPX Gas Handling Manifold | 2023-05-12 The HPX Gas Handling Manifold is an ultra-high purity (UHP) gas pressure regulation and purification system that allows for two |