Who else makes this device?

Name: Nbac 3.0T GE H, Flex
Brand: Nbac 3.0T GE H, Flex

Radiology › DiagnosticCoil, Magnetic Resonance, Specialty

Nbac 3.0t GE H, Flex

Catalogue number 0800187, listed by LMT Medical Systems Gmbh, Germany, under Coil, Magnetic Resonance, Specialty. 9 manufacturers in China are registered for this product code.

Registry build 21.09.26

9manufacturers in China registered for this device type

1catalogue number

2510(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 Nbac 3.0T GE H, Flex
Listed by	LMT Medical Systems Gmbh, Germany
FDA product code	MOS
Device type	Coil, Magnetic Resonance, Specialty
Device class	Class 2
Regulation	21 CFR 892.1000
Establishment	Complaint-file establishment, Manufacturer, Exporter
510(k)	K091047
Record published	2022-02-14
Record revised	2026-06-09 (version 2)

Specifications

Specifications
MRI safety	MR Conditional
Label carries	manufacturing date, serial number
Storage	Handling environment temperature 10 to 40 °C; Handling environment humidity 20 to 80 % RH

Catalogue Numbers

Catalogue numbers for Nbac 3.0T GE H, Flex
Catalogue number	Size	Status
0800187		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
K171515	2017-07-26
K091047	2010-08-18

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.