Singapore HSA registration DE0504235
GE SIGNA Voyager MRI System
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0504235
- Registration Date
- March 18, 2020
- Change Notification Approval Date
- November 08, 2021
- Retention Due Date
- March 17, 2026
Product description
The SIGNA Voyager is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time imaging. The SIGNA Voyager is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body. Body structures for evaluation include, but are 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 Voyager reflect the spatial distribution and/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 FLEX SUITE PRM-P 1.5T GEM FLEX SUITE STN-P 1.5T FLEX SM W/INTER-PCON TDI Posterior Array Anterior Array 1.5T HD Flat GEM Table Breast Array TDI Head Neck Array 1.5T HD Shoulder Array 1.5T GEM PVA 16ch T/R Knee Coil 16ch T/R Hand Wrist Coil GEM Flex Coil 16-S Array, 1.5T GEM Flex Coil 16-M Array, 1.5T GEM Flex Coil 16-L Array, 1.5T GEM Flex Interface 16ch Fixed, 1.5T P-Connector 1.5T 16Ch Breast Coil Discovery MR 450- 1.5T Split Head Coil SIGNA Voyager
- Model Identifier(s)
- M7000SB M7000SC M7000SD M7001NA M7001NB M7001NC M7001ND M7001NE M7001NJ M7001NL M7006CE M7006LE M7006LF M7006LG M7006LH M7006PH M70072CC SIGNA Voyager
About this record
Access comprehensive regulatory information for GE SIGNA Voyager 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 DE0504235 and owned by GE Healthcare (Tianjin) Company Limited. The device was registered on March 18, 2020.
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