Pure Global
Singapore HSA registration DE0503771

GE SIGNA Pioneer MRI System

Singapore flagSingapore·CLASS B·GE Medical Systems LLC·Registered October 24, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0503771
Registration Date
October 24, 2019
Change Notification Approval Date
September 12, 2022
Retention Due Date
October 23, 2025
Product description
The SIGNA Pioneer 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 Pioneer 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
Name
GE Medical Systems LLC
Short Name
GE Medical Systems LLC
Address
3200N. Grandview Blvd.,, Waukesha, WI 53188, UNITED STATES
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
Model Name(s)
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 3.0T 8ch Breast Array without Biopsy Grids 16-ch T/R Hand Wrist Coil 18ch T/R Knee Coil 3.0T GEM PVA (Peripheral Vascular Array) 3.0T Endorectal Coil GEM Flex Coil 16 - S Array GEM Flex Coil 16 - M Array GEM Flex Coil 16 - L Array GEM Flex Interface 16ch Fixed, 3.0T P-Connector 3T 16ch Breast Coil 48CH Head Coil 3.0T AIR Anterior Array Discovery MR750 3.0T-Split Head Coil 3.0T 16Ch Shoulder Coil Signa Pioneer
Model Identifier(s)
M7000GY M7000SK M7000SL M7000SM M7001KA M7001KB M7001KD M7001KE M7001KF M7001KH M7001KK M7001KL M7001KW M7006CM M7006LA M7006LB M7006LC M7006LD M7006PA M7006RA M7100CB M7100EK M7100SH 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 DE0503771 and owned by GE Medical Systems LLC. The device was registered on October 24, 2019.

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