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HSA · registration DE0510099

GE SIGNA Champion MRI system

SingaporeRadiology / ImagingClass BGE Healthcare (Tianjin) Company Limited
Official record identity
Registration number
DE0510099
Model name
8ch T/R Knee Coil; Discovery MR 450 - 1.5T Split Head Coil; 1.5T HD Shoulder Array; 1.5T Express 9E Anterior Array; 1.5T Express Coil - 16E Head Neck Array; 1.5T Endorectal Coil; 16ch T/R Knee Coil; SIGNA Champion
Model identifier
10-F31896; 5182594; 5344905; 5407990; 5407991; O-HLE-015-01899; Q7000075; SIGNA Champion
Registration date
December 02, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Radiology / Imaging
Published parties
Official description

The SIGNA™ Champion system is a whole body magnetic resonance scanner 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 the SIGNA™ Champion system reflect 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.

Additional source fields
Product owner address
No. 266 Jingsan Road, Tianjin Airport Economic Area, Tianjin 300308, China
Registrant address
11 North Buona Vista Drive, #11-07, The Metropolis, Singapore 138589
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.