XENOVIEW 3.0T Chest Coil 44315-03

GUDID 00850045949051

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.

Polarean, Inc.

MRI system coil, radio-frequency

• Primary Device ID: 00850045949051
• NIH Device Record Key: 8d5e7c71-e8d5-4f64-87bf-e09c81f0f33e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XENOVIEW 3.0T Chest Coil
• Version Model Number: Rev B
• Catalog Number: 44315-03
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850045949051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231647

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-01
• Device Publish Date: 2025-09-23

On-Brand Devices [XENOVIEW 3.0T Chest Coil]

• 00850045949051: The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, tran
• 00850045949044: The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, tran