Contains Medical Device Mat. 8625662 (GTIN:04056869014357)


Product Overview

Contains Medical Device Mat. 8625662 (GTIN:04056869014357)
3T Loop 11 cm MR coil kit - 08626835


Device Description

A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.


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: LNH

Device Name: System, Nuclear Magnetic Resonance Imaging

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1000

Third Party Flag: Y

Medical Specialty: RA


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: 04056869014487

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


Educational Resources
Videos