GE Optima MR 450W 1.5T MRI with GEM Option

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

GE HEALTHCARE PTE. LTD.

Class:

Class B medical device

Manufactured by:

GE Medical Systems LLC

Therapeutic area:

Radiology / Imaging

Therapeutic indications:

The GE Optima MR450W 1.5T System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The MR450W System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The GEM Option for I.5T MRI systems is a set of receive-only RF surface coils designed for use with l.5T MRI systems manufactured by GE Healthcare. The GEM Option for I.5T MRI systems is indicated for use for: head,

Product summary:

Device System Info:[System or Procedure Pack], System or Procedure Pack; Models: MR450w 16ch iROC System - M7005WD, MR450w 16ch System - M7005WC, MR450w GEM 32ch System - M7005ZJ, MR450w GEM 32ch+ System - M7005ZL, MR450w 16ch IROC System - M7006WD, MR450w GEM 32ch System - M7006AN, Extremities Positioner Kit, Flex Coils - M7005BA, Foot Ankle Stabilizer, Flex Coils - M7005BB, Knee Stabilizer, Flex Coils - M7005BC, Pediatric Stabilizer, Flex Coils - M7005BD, FCP Flex Positioner - M7005BE, GE 8CH FOOT ANKLE COIL - M5002GF, 16CH HEAD NECK SPINE ARRAY - M7000AN, 8CH BRAIN ARRAY - M3335LZ, 8CH NV ARRAY - M3335M, 8CH CTL ARRAY - M3335TC, 12CH BODY ARRAY - M7000AR, 8CH BODY ARRAY - M3335MC, 8CH BREAST - M3087JG, 8CH CARDIAC ARRAY - M3335MD, 8CH WRIST ARRAY - M3335LJ, 8CH T/R KNEE ARRAY - M3087JF, QUAD EXTREMITY - M3335ME, QUAD WRIST COIL - E8800RA, 3CH SHOULDER ARRAY - M7000AT, 8CH SHOULDER ARRAY - M3340CE, 8CH FOOT/ANKLE ARRAY - M3340CD, GENERAL PURPOSE FLEX COIL - M1085GF, GP FLEX COIL ADAPTER - M7000EP, 8CH COIL INTERFACE DEVICE - E8801RG, PROSTATE ENDORECTAL PROBES - E8801R, GEM Legacy Pad Patient Pad - M7000ZW, Radiation Oncology Positioning Insert - M0030RT, Operator's Console Chair - E8803BE, Sentinelle Breast Table - M7000FG, 1.5T GEM Coil PA - M7000AA, 1.5T GEM Coil HNU - M7000AB, 1.5T GEM Coil AA - M7000AD, 1.5T GEM Coil PV - M7000AS, 1.5T GEM Flat Base Breast Coil w/Biopsy Plate - M7000GE, 1.5T GEM Flat Base Breast Coil w/o Biopsy Plate - M7000GD, 1.5T GEM Flex Suite Premium - M7000SB, 1.5T GEM Flex Suite Standard - M7000SC, 1.5T GEM Flex Small - M7000SD, 1.5T 8Ch TR Knee Coil for Flat Table - M7000FS, 1.5T HD Quad Lower Extremity Coil Flat Table - M7000FT, 1.5T 8ch Wrist Coil for Flat Table - M7000FW, 1.5T 32ch Small AA Coil - M7000FY, 1.5T GE 6-Channel Phased Array Flex Coil - M0049SS, 1.5T HD Breast Array - M3087JL, Precision Breast Array Coil - HDx - E8800C, 16ch Flex Suite, Premium - M7000SE, 16ch Flex Suite, Standard - M7000SF, 1.5T GEM RT Open Array - M7007RT, 1.5T GEM RT Open Array Kit - M7003RT, 1.5T GEM RT Open Array Partial Kit - M7002RT, 1.5T 16 Ch Shoulder Coil - M7006CA, 1.5T 16Ch GEM Flex Coil, Small - M7006LE, 1.5T 16Ch GEM Flex Coil, Medium - M7006LF, 1.5T 16Ch GEM Flex Coil, Large - M7006LG, GEM Flex Interface 16ch Fixed, 1.5T P-Connector - M7006LH

Authorization date:

2012-11-19