Singapore HSA registration DE0508018

GE SIGNA Artist Evo

Singapore flagSingapore·CLASS B·GE Healthcare (Tianjin) Company Limited·Registered April 18, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0508018
Registration Date
April 18, 2023
Retention Due Date
April 17, 2026
Product description
The SIGNA Artist Evo 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 Artist Evo 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)
1.5T GEM PA 1.5T GEM HNU 1.5T GEM PVA Anterior Array 1.5T HD Flat GEM Table Breast Array 1.5T HD Shoulder Array 16ch T/R Knee Coil 16ch T/R Hand Wrist Coil 1.5T Endorectal Coil 1.5T GEM RT Open Array SIGNA Artist Evo
Model Identifier(s)
M7000AA M7000AB M7000AS M7001NB M7001NC M7001NE M7001NL M7006CE M7006CL M7007RT SIGNA Artist Evo
About this record

Access comprehensive regulatory information for GE SIGNA Artist Evo in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508018 and owned by GE Healthcare (Tianjin) Company Limited. The device was registered on April 18, 2023.

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