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GE Optima CT520 CT Scanner System - HSA Registration DE0017414

Access comprehensive regulatory information for GE Optima CT520 CT Scanner System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0017414 and owned by GE HangWei Medical Systems Co. Ltd. The device was registered on August 14, 2015.

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 C
DE0017414
GE Optima CT520 CT Scanner System
HSA Registration Number: DE0017414
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Product Description

The GE Optima CT520 Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The GE Optima CT520 CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90221400
Registration Information
Registration Number
DE0017414
Registration Date
August 14, 2015
Change Notification Approval Date
May 21, 2019
Retention Due Date
August 13, 2025
Product Owner
Short Name
GE HangWei Medical Systems Co. Ltd
Address
West Area of Building No.3,, No.1 Yongchang North Road., Beijing Economic and Technological, Development Area, BeiJing 100176, 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)
Standard cover kit CONNECTPRO HIS-RIS SW KEY LINUX HOSPITAL INFO SYS RADIOLOGY SYS INFO AVA Xpress Advantage CTC Pro3D EC AutoBone Xpress CT Perfusion 4D Neru CT Perfusion 4D Multi-Organ DentaScan Gantry Accessory I/F Kit Optima CT520 Recon enhancement Package Overlapped Reconstruction Standard cover kit Organ Dose Modulation Ultraย Kernel Xtream Injector Enhanced Xtream Injector Smart Score Pro Acquisition Software ECG Trace on OC Software Exam Split Volume Viewer
Model Identifier(s)
B70762RT B7500LN B75022AE B75032AE B75042AE B75062AE B75072AE B7540LS B75492CB B76922CB B77002CB B77012CB B77092CB B77102CB B77112CB B77372CA B77382CA B7850PL B7864KC B7864KH B7870JA