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GE Brivo CT385 Computed Tomography X-Ray System - HSA Registration DE0013017

Access comprehensive regulatory information for GE Brivo CT385 Computed Tomography X-Ray 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 DE0013017 and owned by GE HangWei Medical Systems Co. Ltd. The device was registered on May 28, 2013.

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
DE0013017
GE Brivo CT385 Computed Tomography X-Ray System
HSA Registration Number: DE0013017
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Product Description

The GE Brivo CT385 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. 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 Brivo CT385 CT Scanner System is indicated for head, whole body, 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
DE0013017
Registration Date
May 28, 2013
Change Notification Approval Date
May 21, 2019
Retention Due Date
May 27, 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)
Phantom P9150TS Body Strap A Xray tube assembly PDU PDU DentaScan Connect Pro SW Exam Split FX Collimator Generator Freedom Workspace Straps Auto Traction Low profile head holder kit Catheter Bag Holder Long Body Strap Auto Filter and Transfer Neuro Filter Option Dolly Collector TIO Antiseismic Kit Brivo CT385 GANTRY Brivo CT385 GANTRY Operator Console Operator Console Gantry Accessory I/F Kit (AC Outlet & IPC Board) AWE connection Advanced Vessel Analysis Xpress (AVA Xpress) Advantage CTC Pro AutoBone Xpress CT Perfusion 4D MultiOrgan (Perf 4 - Neuro) CT Perfusion 4D MultiOrgan (Perf 4 - MultiOrgan) Ship collector Tech Pub and Software System Grade Collector Tech Pub and Software System Grade Collector System Grade Collector System Grade Collector System Grade Collector Recon enhancement Package Recon enhancement Package System Grade Collector Collimator Xtream Injector (Class 1 SW & Cables) Enhanced Xtream Injector (Class 4 SW & Cables) Volume Viewer Volume Viewer Xtream Injector (Class 1 SW & Cables) Enhanced Xtream Injector (Class 4 SW & Cables) Catheter Bag Holder Knee Pad Patient Band Kit Arm Support
Model Identifier(s)
2144715 2169679 2232785-4, 5363417 (MX135CT) 2326492-34 2326492-35 2360557 2371407 5133030 5140001-6 (H4 COLL - GEMS) 5167185-2 5168666-3 5198277 5199283 (B75372CA) 5212429 5212948 5213288-2 5220827 5346612 5394347 5402412 5405619 5411378-11 5411378-31 5413342 5418595 5428406 5428408 5428410 5428414 5428416 5433250 5439928 5441467 5445604 5446305 5450739 5450831 5451541 5456615 5456616 5458299 5640001 (H4 COLL - GEHW) B75052BE B75062BE B7540LD B76882AD B77372CA B77382CA P9140HD P9140SK P9140SL P9140TL