Singapore HSA registration DE0019143
Shimadzu FDR Visionary Suite
Singapore·CLASS C·Shimadzu Corporation·Registered April 06, 2017Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0019143
- Registration Date
- April 06, 2017
- Change Notification Approval Date
- April 03, 2025
- Retention Due Date
- April 05, 2026
Product description
The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The device is not intended for mammographic applications.”
Product Owner
- Short Name
- Shimadzu Corporation
- Address
- 1, Nishinokyo-Kuwabaracho,, Nakagyo-ku, Kyoto 604-8511, Japan, JAPAN
Registrant
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
- Model Name(s)
- X-Ray Tube X-Ray Tube X-Ray Tube X-Ray Tube X-Ray Radiography Table X-Ray Radiography Stand X-Ray Radiography Stand X-Ray Tube Support Flat Panel Sensor Detector Flat Panel Sensor Detector Flat Panel Sensor Detector Flat Panel Sensor Detector Flat Panel Sensor Detector Flat Panel Sensor Detector Flat Panel Sensor Detector Digital Radiography System DR-ID 900CL Control Cabinet DR-ID 900MC Flat Panel Sensor Detector X-Ray Collimator X-Ray High Voltage Generator X-Ray High Voltage Generator X-Ray High Voltage Generator
- Model Identifier(s)
- 0.6/1.2P324DK-125 0.6/1.2P324DK-85 0.6/1.2P364DK-125 0.6/1.2P364DK-85 BK-200 BR-120 BR-120T CH-200 DR-ID 1201SE DR-ID 1202SE DR-ID 1211SE DR-ID 1212SE DR-ID 601SE DR-ID 602SE DR-ID 611SE DR-ID 900 DR-ID 900CL DR-ID 900MC DR-ID 900MC V 14 DR-ID 911SE R-300 UD150B-40 UD150L-40 UD150V-40
About this record
Access comprehensive regulatory information for Shimadzu FDR Visionary Suite in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019143 and owned by Shimadzu Corporation. The device was registered on April 06, 2017.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C