System, Nuclear Magnetic Resonance Imaging

MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-s

GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Disc

Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products

Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355,

Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and

Ingenia 1.5T, magnetic resonance imaging system.

Ingenia 3.0T, magnetic resonance imaging system.

Ingenia 1.5T R5, magnetic resonance imaging system.

Ingenia 3.0T R5, magnetic resonance imaging system.

Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an o

Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an

MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscop

All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic

GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devic

GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.

Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.

Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applicati

GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa MR 750

GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337

SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYST

Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physio

GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device.

GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.

GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.

Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.

MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the th

GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spe

MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.

Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scann

IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.

Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager

Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.

EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Depen

Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with

Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System Product Usage: Nuclear magnetic resonance imaging

Siemens MAGNETOM Verio Use: Nuclear resonance imaging system

Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device.

GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used t