Singapore HSA registration DE0019228
GE SIGNA Architect MRI system
Singapore·CLASS B·GE Medical Systems LLC·Registered May 05, 2017Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0019228
- Registration Date
- May 05, 2017
- Change Notification Approval Date
- April 21, 2025
- Retention Due Date
- May 04, 2026
Product description
The SIGNA™ Architect 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™ Architect system reflects 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 Medical Systems
- Address
- 3200 N. Grandview Blvd., Waukesha, WI 53188,, UNITED STATES
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)
- 3.0T 6-ch Flex Coil Set with Integrated Preamp 3.0T DV24 GEM Head Neck Unit 3.0T 16-ch GEM Flex Suite, Premium (contains SM, MD, & LG) 3.0T 16-ch GEM Flex Suite, Standard (contains MD, & LG) 3.0T 16-ch Small Flex Coil with Interface 3.0T Anterior Array 3.0T Shoulder Phased Array 3.0T HD Breast Array 3.0T 16ch TR Hand Wrist coil 3.0T 18ch TR Knee Coil 3.0T Peripheral Vascular Array 3.0T DV24 GEM Posterior Array 3.0T 48-ch Head Coil MR750w to Architect Upgrade 3T GEM RT Open Array SIGNA Architect
- Model Identifier(s)
- M0050SS M7000GH M7000SK M7000SL M7000SM M7001KB M7001KE M7001KF M7001KK M7001KL M7001KW M7002AH M7006CD M7006DB M7008RT SIGNA Architect
About this record
Access comprehensive regulatory information for GE SIGNA Architect 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 DE0019228 and owned by GE Medical Systems LLC. The device was registered on May 05, 2017.
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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