Swoop Transmit and Receive Radio Frequency Head Coil

The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It…

Registry build 21.09.26

The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It consists of one linear mode transmit coil, and an 8-channel receive phased array.

9manufacturers in China registered for this device type
4catalogue 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 Swoop Transmit and Receive Radio Frequency Head Coil
Listed by Hyperfine Operations, Inc.
FDA product code MOS
Device type Coil, Magnetic Resonance, Specialty
Device class Class 2
Regulation 21 CFR 892.1000
510(k) K250236
Record published 2025-12-04
Record revised 2025-03-13 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number
Storage Handling environment temperature 15 to 30 °C; Storage environment temperature 15 to 30 °C; Handling environment humidity 15 to 85 % RH; Storage environment humidity 15 to 85 % RH

Catalogue Numbers

Catalogue numbers for Swoop Transmit and Receive Radio Frequency Head Coil
Catalogue number Size Status
v2.2 In distribution
V2.0 (815-11016-04) In distribution
850-11016-05 In distribution
900-11011-06 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

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