XENOVIEW 3.0T Chest Coil

Primary DI
00850045949044
Brand
XENOVIEW 3.0T Chest Coil
Company
Polarean, Inc.
Model
Rev C
Catalog number
44315-01
Device description
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.
Published
2025-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212239000XENOVIEW 3.0T Chest CoilPolarean, Inc.2022-12-23MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045949044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045949044008500459490448500459490440850045949044

GMDN Terms#

Term, Definition table
TermDefinition
MRI system coil, radio-frequencyA radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078629330
Device count
1
Combination product
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045949136XENOVIEW VDP1.2.2357902026-05-07
00850045949075XENOVIEW 3.0T Chest Coil-GE PremierRev A44315-042025-12-19
00850045949082HPX Polarization Measurement StationRev. E428812025-10-13
00850045949099XENOVIEW Dose Delivery Bag, Carton of 50, 1,000 mLRev A47471-1002025-10-13
00850045949105XENOVIEW Dose Delivery Bag, Carton of 50, 750 mLRev A47471-0752025-10-13
00850045949112XENOVIEW Dose Delivery Bag, Carton of 50, 500 mLRev A47471-0502025-10-13
00850045949129XENOVIEW Dose Delivery Bag, Carton of 50, 300 mLRev A47471-0302025-10-13
00850045949051XENOVIEW 3.0T Chest CoilRev B44315-032025-09-23
00850045949006HPX HyperpolarizerRev E498202023-05-04
00850045949013XENOVIEW Dose Delivery BagRev B44639-012023-05-04
00850045949020HPX Polarization Measurement StationRev. D428812023-05-04
00850045949037HPX Gas Handling ManifoldRev E456602023-05-04

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