Who else makes this device?

Name: Body 18 MR Coil set 3T 098
Brand: Body 18 MR Coil set 3T 098

Body 18 MR Coil Set 3t 098 · Coil, Magnetic Resonance, Specialty → Radiology

9manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Body 18 MR Coil set 3T 098
Listed by	Siemens Healthcare Limited, Canada
FDA product code	MOS
Device type	Coil, Magnetic Resonance, Specialty
Device class	Class 2
Regulation	21 CFR 892.1000
Establishment	Contract manufacturer, Manufacturer, Exporter
Record published	2016-09-24
Record revised	2021-11-17 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Body 18 MR Coil set 3T 098
Catalogue number	Size	Status
10185538		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
K063373	2006-11-17

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.

Body 18 MR Coil Set 3t 098