국가: 싱가포르
언어: 영어
출처: HSA (Health Sciences Authority)
GE HEALTHCARE PTE. LTD.
Class B medical device
GE Healthcare (Tianjin) Company Limited
Radiology / Imaging
The SIGNA Artist is a whole body magnetic resonance scanners designed to support high resolution, high signal-to- noise ratio, and short scan times. It 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/or functions 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. Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA Artist reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Device System Info:[System or Procedure Pack], MRI system with coils.; Models: SIGNA Artist - SIGNA Artist, MR450w GEM to Artist Upgrade - M7006KC, MR450w to Artist Upgrade - M7006KD, 1.5T GE 6-Channel Phased Array Flex Coil - M0049SS, 1.5T GEM PA - M7000AA, 1.5T GEM HNU - M7000AB, 1.5T GEM PVA - M7000AS, Anterior Array - M7001NB, 1.5T HD Flat GEM Table Breast Array - M7001NC, 1.5T HD Shoulder Array - M7001NE, 1.5T GEM RT Open Array - M7007RT, 1.5T HD 8CH Cardiac Array - M3335MD, Vanguard Breast MRI Table - M7000FG, 1.5T 32Ch Cardiac Coil - Anterior - M7000FY, 16Ch Shoulder Coil - M7006CA, 1.5T 16ch GEM FLEX SUITE PRM-P - M7000SB, 1.5T 16ch GEM FLEX SUITE STN-P - M7000SC, 1.5T 16ch FLEX SM W/INTER-PCON - M7000SD, 16ch T/R Knee Coil - M7001NL, 16ch T/R Hand Wrist Coil - M7006CE, 1.5T 16Ch Breast Coil - M7006PH, GEM Flex Coil 16-S Array, 1.5T - M7006LE, GEM Flex Coil 16-M Array, 1.5T - M7006LF, GEM Flex Coil 16-L Array, 1.5T - M7006LG, GEM Flex Interface 16ch Fixed, 1.5T P-Connector - M7006LH, 1.5T 16ch Shoulder Coil - M7100SG
2018-03-14