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GE SIGNA Victor - HSA Registration DE0508315

Access comprehensive regulatory information for GE SIGNA Victor in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508315 and owned by GE Healthcare (Tianjin) Company Limited. The device was registered on July 20, 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.

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CLASS B
DE0508315
GE SIGNA Victor
HSA Registration Number: DE0508315
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Product Description

The SIGNAโ„ข Victor 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 SIGNAโ„ข Victor 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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508315
Registration Date
July 20, 2023
Retention Due Date
July 19, 2025
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 HD BREAST ARRAY Discovery MR 450-1.5T Split Head Coil 1.5T HD Shoulder Array 1.5T Express 9E Anterior Array 1.5T Express Coil -16E Head Neck Array 1.5T Endorectal Coil SIGNA Victor
Model Identifier(s)
2401500 5182594 5344905 5407990 5407991 O-HLE-015-01899 SIGNA Victor