Singapore HSA registration DE0510311
Vieworks VIVIX-S FW Digital Imaging System
Singapore·CLASS B·Vieworks Co., Ltd·Registered February 06, 2025Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0510311
- Registration Date
- February 06, 2025
- Retention Due Date
- February 05, 2026
Product description
VIVIX-S FW (FXRD-3643FW, 4343FW, and 2530FW) are digital flat panel detectors that is used for screening and diagnosis of disease of injury. These detectors are intended for use by a qualified/trained doctor or technician on both adult subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
Product Owner
- Short Name
- Vieworks Co., Ltd
- Address
- 41-3, Burim-ro 170beon-gil, Dongan-, Anyang-si, Gyeonggi-do, 14055, KOREA, REPUBLIC OF
Registrant
- Address
- 79 SCIENCE PARK DRIVE, CINTECH IV, #02-01/08, SINGAPORE 118264
Importer
- Address
- 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384 79 SCIENCE PARK DRIVE, CINTECH IV, #02-01, SINGAPORE 118264
Model information
- Model Name(s)
- Battery Pack Battery Charger VIVIX-S FW VIVIX-S FW VIVIX-S FW SCU Lite Cradle SCU mini Vxvue
- Model Identifier(s)
- FXRB-04A FXRC-04A FXRD-2530FAW FXRD-3643FAW FXRD-4343FAW FXRP-03A FXRR-01A FXRS-04A Vxvue
About this record
Access comprehensive regulatory information for Vieworks VIVIX-S FW Digital Imaging 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 DE0510311 and owned by Vieworks Co., Ltd. The device was registered on February 06, 2025.
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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