Singapore HSA registration DE0505108
Canon CT Scanner Aquilion One TSX-306A
Singapore·CLASS C·Canon Medical Systems Corporation·Registered November 05, 2020Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0505108
- Registration Date
- November 05, 2020
- Change Notification Approval Date
- May 14, 2025
- Retention Due Date
- November 04, 2025
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 Corporation
- Address
- 1385, Shimoishigami, Otawara-Shi,, Tochigi 324, 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 Footswitches Rear Operating Panel Kit Couch Lateral Movement Unit Couch Lateral Movement Unit Handy Snap Reconstructuction Processing Unit Area Finder Kit Display Console Kit Display Console Kit Injector Synchronization System Injector Synchronization System Respiratory-Gated Scan System Diagnostic Image Display Unit CT SCANNER Aquilion ONE CT SCANNER Aquilion ONE CT Fluoroscopy
- Model Identifier(s)
- CAFS-007A CAGP-003A CALU-001A CALU-001B CAXS-001A CCRS-003C CGAP-001A CGS-94A CGS-94B CKIS-004B CKIS-005A CKRS-005A CMM-004B TSX-306A TSX-306A TSXF-004A
About this record
Access comprehensive regulatory information for Canon CT Scanner Aquilion One TSX-306A in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505108 and owned by Canon Medical Systems Corporation. The device was registered on November 05, 2020.
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