System, Nuclear Magnetic Resonance Imaging

Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146

SmartPath to dStream for 3.0T, Model Number: 782145;

SmartPath to dStream for 1.5T, Model Number: 782146;

Intera CV, Model Number: 781107;

Intera 3.0T Quasar Dual, Model Number: 781150;

Intera 1.5T R11, Model Number: 781170;

Intera 1.5T Power/Pulsar, Model Number: 781105;

Intera 1.5T Omni/Stellar, Model Number: 781104;

Intera 1.5T Master/Nova, Model Number: 781106;

Intera 1.5T Explorer/Nova Dual, Model Number: 781108;

Intera 1.5T, Model Numbers: 781195 and 781295;

Intera 1.0T Power/Pulsar, Model Number: 781103;

Intera 1.0T Omni/Stellar, Model Number: 781102;

Intera 0.5T Standard, Model Number: 781101;

Enterprise 1.5T, Model Number: 781145;

SIGNA MR380, NMRI system, Non-US Only

SIGNA MR355, SIGNA MR360, NMRI system

Optima MR360, NMRI system

Brivo MR355, NMRI system

SIGNA Creator, SIGNA Explorer, NMRI systems

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,

SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System

SIGNA Architect, Nuclear Magnetic Resonance Imaging System

Discovery MR750w 3.0T, whole body magnetic resonance scanner

SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any

SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities,

SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any

MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Nu

MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) N

Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.

Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.

Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation

Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation

Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.

Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (RE

Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF

Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orienta

SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only

SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System

Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only

SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System