Singapore HSA registration DE0007946
GE Healthcare Optima CT660 Scanner System
Singapore·CLASS C·GE Healthcare Japan Corporation·Registered November 17, 2011Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90221400
Registration information
- Registration Number
- DE0007946
- Registration Date
- November 17, 2011
- Change Notification Approval Date
- May 21, 2019
- Retention Due Date
- November 16, 2025
Product description
The system is intended to be used for head, whole body Computed Tomography applications. The 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, including Axial, Cine, Helical (Volumetric), 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 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
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
Model information
- Model Name(s)
- Standard software options 0.4sec Rotation 72kW (100KVA) QCTPRO 3D SPINE BMD SYSTEM (uses DICOM images) Advantage CTC Pro for OC AutoBone Xpress on OC Card IQ Reveal on OC Integrated Injector Class 1 Perfusion4 Neuro for OC Integrated Injector Class 4 Perfusion4 Multi-Organ for OC In Room Monitor RIO Cable System Dentascan on OC ASIR UPGRADE Snapshot Assist Shuttle Scan Package Boom in a Room monitor SnapShot Imaging pkg SmartScore Pro Complete Pkg Advanced Cardiac Plg w/ new ECG trace monitor SmartSpeed (0.5sec Rotation) SmartScore pro acquisition 0.35sec rotation （Key Name: Sub 0.4） ECG Trace on Console Cardiac Enahancement Filter SnapShot Pulse option Volume Shuttle Option (Axial Shuttle） Card IQ Snapshot SmartStep w/ Boom pkg SmartStep w/o Boom pkg CardEP on the OC Adapter - Smart Step Advantage 4D Cardiac cable kit for IPC
- Model Identifier(s)
- 5375970-40,5375970-41 B75002GS B75002MP B7501MW B75032AE B75042AE B75052AE B75052BE B75062AE B75062BE B75072AE B75202FJ B75322FJ,B77562FJ B7540LS B75452FJ B75532FJ (5427578) B75612FJ B7710LN B77462FJ B77472FJ B77482FJ B77912AD B78372AD B78392AD B78402AD B78412AD B78462AD B78472AD B78482AD B7864SM B7864SN B7868EP B79252AD B7940DC E8007TB
About this record
Access comprehensive regulatory information for GE Healthcare Optima CT660 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 DE0007946 and owned by GE Healthcare Japan Corporation. The device was registered on November 17, 2011.
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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