What is FDA product code OUO?

Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical mr images are used for pet attenuation correction.

Radiology › DiagnosticTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

3t Loop 4 Cm MR Coil Kit

Name: 3T Loop 4 cm MR coil kit
Brand: 3T Loop 4 cm MR coil kit

Contains Medical Device Mat. 10185556 (GTIN:04056869014821)

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shanghai (1), Guangdong (1), Tianjin (1).

Chinese manufacturers registered for FDA product code OUO
Manufacturer	City	Province	Registered as	Device types
Shanghai United Imaging Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	12
Siemens Shenzhen Magnetic Resonance Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
GE Healthcare (Tianjin) Company Limited	Tianjin	Tianjin	Specification developer	5

Record

Regulatory record for 3T Loop 4 cm MR coil kit
Listed by	Siemens Healthcare Limited, Canada
FDA product code	OUO
Device type	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device class	Class 2
Regulation	21 CFR 892.1200
Establishment	Contract manufacturer, Manufacturer, Exporter
510(k)	K121434
Record published	2016-09-24
Record revised	2021-11-17 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for 3T Loop 4 cm MR coil kit
Catalogue number	Size	Status
08626850		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	GE Medical Systems, L.L.C.	13
Symphony™	Qfix	3
Flex small 4 MR coil set 3T	Siemens Healthcare Limited	2
Lithotomy AirShuttle™	Qfix	1
ZiFix™	Qfix	1
mMR Head	Siemens Healthcare Limited	1
mMR Head set	Siemens Healthcare Limited	1
mMR Head/Neck coil set	Siemens Healthcare Limited	1
mMR Head/Neck Matrix coil	Siemens Healthcare Limited	1
mMR Body coil set	Siemens Healthcare Limited	1
uPMR	Shanghai United Imaging Healthcare Co., Ltd.	1
3T Body Matrix MR coil set, Verio	Siemens Healthcare Limited	1

Showing 12 of 22. All products under Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Recalls Naming This Product

7 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of 3T Loop 4 cm MR coil kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Siemens Medical Solutions USA, Inc.	510(k) number	2025-08-28	Class I	Under Investigation by firm	There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the	101 units
Siemens Medical Solutions USA, Inc.	510(k) number	2025-08-28	Class I	Under Investigation by firm	There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the	56 units
Siemens Medical Solutions USA, Inc.	510(k) number	2025-08-28	Class I	Under Investigation by firm	There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the	59 units
Siemens Medical Solutions USA, Inc.	510(k) number	2025-08-28	Class I	Under Investigation by firm	There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the	78 units
Siemens Medical Solutions USA, Inc.	510(k) number	2025-08-28	Class I	Under Investigation by firm	There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the	498 units
Siemens Medical Solutions USA, Inc.	510(k) number	2015-12-07	Class II	Other	Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blow	in US 3752 units	2017-06-21
Siemens Medical Solutions USA, Inc.	510(k) number	2015-03-09	Class II	Nonconforming Material/Component	The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.	132	2016-08-17

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.