DuoFLEX® Coil Suite

The 24cm Right Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 1520G-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared…

Registry build 21.09.26

The 24cm Right Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 1520G-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 4 or 8 channels for imaging.

9manufacturers in China registered for this device type
20catalogue numbers in this listing

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 DuoFLEX® Coil Suite
Listed by M R Instruments, Inc.
FDA product code MOS
Device type Coil, Magnetic Resonance, Specialty
Device class Class 2
Regulation 21 CFR 892.1000
510(k) K173290
Record published 2022-03-10

Specifications

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

Catalogue Numbers

Catalogue numbers for DuoFLEX® Coil Suite
Catalogue number Size Status
FC3000S-8R In distribution
FC3000S-8R In distribution
FC1500S-8R In distribution
FC3000G-8R In distribution
FC1520G-8R In distribution
FC3000S-8R In distribution
FC3000S-8R In distribution
FC1520G-8R In distribution
FC3000G-8R In distribution
FC1500S-8R In distribution
FC1520G-8R In distribution
FC3000S-8R In distribution
FC3000G-8R In distribution
FC1520G-8R In distribution
FC1500S-8R In distribution
FC1500S-8R In distribution
FC1520G-8R In distribution
FC3000G-8R In distribution
FC1500S-8R In distribution
FC3000G-8R 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
RFT Shenzhen RF Tech Co., Ltd. 18
AtamA™ System Monteris Medical Corp 17
Philips Sentinelle Philips Medical Systems Nederland B.V. 16
Dunlee Philips Medical Systems Nederland B.V. 16

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

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