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Canon Aquilion CT Scanner Exceed LB TSX-202A - HSA Registration DE0507696

Access comprehensive regulatory information for Canon Aquilion CT Scanner Exceed LB TSX-202A in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507696 and owned by Canon Medical Systems Corporation. The device was registered on January 18, 2023.

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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CLASS C
DE0507696
Canon Aquilion CT Scanner Exceed LB TSX-202A
HSA Registration Number: DE0507696
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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 Exceed LB 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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0507696
Registration Date
January 18, 2023
Change Notification Approval Date
June 21, 2024
Retention Due Date
January 17, 2026
Product Owner
Short Name
Canon Medical Systems Corporation
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 Footswitches Gantry rear control panel kit Couch lateral movement unit Handy Snap Self-Propelled CT Scan Base Kit Self-Propelled CT Scan Base Kit Green laser kit Display Console Kit Injector Synchronization System Injector Synchronization System Diagnostic Image Display Unit CT imaging QA kit for RTP CT SCANNER Aquilion Exceed LB CT Fluoroscopy CT Fluoroscopy
Model Identifier(s)
CAFS-007A CAGP-007A CALU-004A CAXS-001A CGBA-031A CGBA-031B CGGL-002A CGS-94A CKIS-004B CKIS-005A CMM-004B CZTG-001A TSX-202A TSXF-004B TSXF-005A