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Canon Aquilion ONE TSX-308A - HSA Registration DE0510214

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.

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CLASS C
DE0510214
Canon Aquilion ONE TSX-308A
HSA Registration Number: DE0510214
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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 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.

Device 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 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