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…

Registry build 21.09.26

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.

9manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (3), Guangdong (2), Tianjin (2).

Chinese manufacturers registered for FDA product code MOS
Manufacturer City Province Registered as Device types
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Siemens Shenzhen Magnetic Resonance Ltd. Shenzhen Guangdong Contract manufacturer 8
Philips Healthcare (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
GE Healthcare (Tianjin) Company Limited Tianjin Tianjin Specification developer 5
GE Healthcare (China) Co., Ltd. – Tianjin Tianjin Tianjin Specification developer 3
Shenzhen RF Tech Co., Ltd. Shenzhen Guangdong Complaint-file establishment 2
Shanghai Chenguang Medical Technologies Co., Ltd. Shanghai Shanghai Contract manufacturer 2
Shanghai Chenshi Medical Instruments Co., Ltd. Shanghai Shanghai Exporter 2

Record

Regulatory record for Xenoview 3.0T Chest Coil-GE Premier
Listed by Polarean, Inc., United States
FDA product code MOS
Device type Coil, Magnetic Resonance, Specialty
Device class Class 2
Regulation 21 CFR 892.1000
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K243316
Record published 2025-12-19

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Xenoview 3.0T Chest Coil-GE Premier
Catalogue number Size Status
Rev A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dunlee Sentinelle Philips Medical Systems Nederland B.V. 192
Invivo Philips DS North America LLC 185
Philips Philips DS North America LLC 88
Coil, Magnetic Resonance, Specialty Usa Instruments, Inc. 50
Philips Shanghai Chenguang Medical Technologies Co., Ltd. 50
GE Philips DS North America LLC 41
MR Coils Philips Medical Systems Nederland B.V. 37
MRI Coils Philips DS North America LLC 24
DuoFLEX® Coil Suite M R Instruments, Inc. 20
RFT Shenzhen RF Tech Co., Ltd. 18
AtamA™ System Monteris Medical Corp 17
Philips Sentinelle Philips Medical Systems Nederland B.V. 16

Showing 12 of 713. All products under Coil, Magnetic Resonance, Specialty

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K243316 2024-11-19
K231647 2023-06-29
K212239 2022-12-23

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer