Singapore HSA registration DE0510214
Canon Aquilion ONE TSX-308A
Singapore·CLASS C·Canon Medical Systems Asia Pte Ltd·Registered January 06, 2025Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0510214
- Registration Date
- January 06, 2025
- Retention Due Date
- January 05, 2026
Product description
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc. The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
Product Owner
- Short Name
- Canon Medical Systems Asia Pte Ltd
- Address
- 1385 Shimoishigami, Otawara-shi,, Tochigi 324-8550, JAPAN
Registrant
- Address
- 211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Importer
- Address
- 211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Model information
- Model Name(s)
- Rear Operating Panel Kit Couch Lateral Movement Unit Handy Snap Reconstruction Processing Unit Area Finder Kit Gantry Illumination Kit Extension Kit for Display Console Display Console Kit Injector Synchronization System Injector Synchronization System Respiratory-Gated Scan System Diagnostic Image Display Unit Large Screen Monitor Connection Kit Canon Aquilion ONE CT Fluoroscopy
- Model Identifier(s)
- CAGP-008A CALU-005A CAXS-001A CCRS-003C CGAP-003A CGLT-002A CGS-111A CGS-93B CKIS-004B CKIS-005A CKRS-005A CMM-005A CMM-006A TSX-308A TSXF-008A
About this record
Access comprehensive regulatory information for Canon Aquilion ONE TSX-308A in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510214 and owned by Canon Medical Systems Asia Pte Ltd. The device was registered on January 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C