Singapore HSA registration DE0510099

GE SIGNA Champion MRI system

Singapore flagSingapore·CLASS B·GE Healthcare (Tianjin) Company Limited·Registered December 02, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0510099
Registration Date
December 02, 2024
Retention Due Date
December 01, 2025
Product 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.
Product Owner
Short Name
GE Healthcare (Tianjin) Company Limited
Address
No. 266 Jingsan Road, Tianjin Airport Economic Area, Tianjin 300308, CHINA
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
Model Name(s)
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(s)
10-F31896 5182594 5344905 5407990 5407991 O-HLE-015-01899 Q7000075 SIGNA Champion
About this record

Access comprehensive regulatory information for GE SIGNA Champion MRI system in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510099 and owned by GE Healthcare (Tianjin) Company Limited. The device was registered on December 02, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B