Product Overview

MRI Coil
mMR Head/Neck Matrix coil - 10606489


Device Description

A diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The nuclear medicine images and the magnetic resonance images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and MRI portions of the system may be used independently or in combination; their images may be transferred to other systems for additional processing.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: OUO

Device Name: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Device Class: 2

Physical State: The combined imager includes hardware and software for acquisition and reconstruction of both PET and MR images. Software for image fusion/registration is also included

Definition: 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.

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: MRI creates images based on the spatial distribution of hydrogen nuclei; PET creates images based on the biodistribution of a radiopharmaceutical. Radiation from the MRI is non-ionizing radiofrequency radiation; radiation from the PET radiopharmaceutical is ionizing.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: whole body

Regulation Number: 892.1200

Third Party Flag: N

Medical Specialty: RA


Device Identifiers

Device Id: 04056869015118

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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