Singapore HSA registration DE0017825
GE Signa Pioneer MRI System
Singapore·CLASS B·GE Healthcare Japan Corporation·Registered January 26, 2016Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90181300
Registration information
- Registration Number
- DE0017825
- Registration Date
- January 26, 2016
- Change Notification Approval Date
- July 28, 2017
- Retention Due Date
- January 25, 2026
Product description
The SIGNA Pioneer 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 Pioneer 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
- Address
- 7-127, Asahigaoka 4-chome, Hino-shi, Tokyo 191-8503, JAPAN
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 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model information
- Model Name(s)
- 3.0T 32ch Head Coil 3T GEM SM ANTERIOR ARRAY (3T Geometry Embracing Method Small Anterior Array) 16-ch GEM Flex Suite, Premium (contains SM, MD, & LG) 16-ch GEM Flex Suite, Standard (contains MD, & LG) 16-ch Small Flex Coil with Interface TDI Posterior Array 3.0T AA (Anterior Array) TDI Head Neck Array 3.0T HD Shoulder Array 3.0T 8ch Breast Array with Biopsy Grids TDI Posterior DMS Filler (Total Digital Imaging Posterior Digital Micro Switching Filler) 3.0T 8ch Breast Array without Biopsy Grids 16-ch T/R Hand Wrist Coil 18ch T/R Knee Coil 8ch Foot Ankle Coil 3.0T GEM PVA (Peripheral Vascular Array) Signa Pioneer
- Model Identifier(s)
- E8800DB M7000GY M7000SK M7000SL M7000SM M7001KA M7001KB M7001KD M7001KE M7001KF M7001KG M7001KH M7001KK M7001KL M7001KM M7001KW SIGNA Pioneer
About this record
Access comprehensive regulatory information for GE Signa Pioneer 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 DE0017825 and owned by GE Healthcare Japan Corporation. The device was registered on January 26, 2016.
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.
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