Singapore HSA registration DE0509489
Shimadzu Shimadzu X-RAY R/F SYSTEM FLUOROspeed
Singapore·CLASS C·Shimadzu Corporation·Registered July 04, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0509489
- Registration Date
- July 04, 2024
- Retention Due Date
- July 03, 2025
Product description
The FLUOROspeed X1 is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed X1 may be used for emergency treatment on an outpatient basis, as well as for bedside examinations. The FLUOROspeed X1 is used for radiographic and fluoroscopic examinations of skull, spine, chest, abdomen, extremities and other body parts. The equipment is NOT intended to be used for mammography applications. The equipment is used for total patient population including pediatric patients. The equipment is intended for use by qualified/trained personnel, such as doctors or radiology technicians
Product Owner
- Short Name
- Shimadzu Corporation
- Address
- 1 Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto 604-8511, JAPAN
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)
- X-RAY R/F SYSTEM FLUOROspeed
- Model Identifier(s)
- X-RAY R/F SYSTEM FLUOROspeed
About this record
Access comprehensive regulatory information for Shimadzu Shimadzu X-RAY R/F SYSTEM FLUOROspeed in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509489 and owned by Shimadzu Corporation. The device was registered on July 04, 2024.
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