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Canon Aquilion Precision CT Scanner - HSA Registration DE0504043

Access comprehensive regulatory information for Canon Aquilion Precision CT Scanner in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504043 and owned by Canon Medical Systems Corporation. The device was registered on January 20, 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.

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CLASS C
DE0504043
Canon Aquilion Precision CT Scanner
HSA Registration Number: DE0504043
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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. The Aquilion Precision has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0504043
Registration Date
January 20, 2020
Change Notification Approval Date
September 11, 2020
Retention Due Date
January 19, 2026
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 Operating Panel Kit Couch Lateral Movement Unit Handy Snap Color Printer Interface FIRST Display System for Dental Application Fly Through ECG-Gated Scan System SURE Subtraction Scan System vHP Injector Synchronization System Injector Synchronization System Injector Synchronization System Orbital Synchronized Scan System Respiratory-Gated Scan System Respiratory-Gating System Diagnostic Image Display Unit DICOM3 Storage SCP Systems DICOM3 MWM SCU Systems DICOM3 MPPS Systems DICOM3 Q/R SCP Systems DICOM3 Q/R SCU Systems DICOM3 Storage Commitment SCU Software DICOM PGP Profile System Additional Connection Kit 4D Airways Analysis Body Organ Perfusion Cardiac Function Analysis Software (CFA) Cerebral Blood Perfusion Study (CBP Study) SURE Cardio Scoring Colon View Dual Energy Composition Analysis Dual Energy System Fat Index View Lung Volume Analysis SURE Plaque SURE Subtraction Angio SURE Subtraction Iodine Mapping SURE Subtraction Lung SURE Subtraction Ortho Wide Volume Brain Perfusion Vessel View CT SCANNER Aquilion Precision CT Fluoroscopy
Model Identifier(s)
CAGP-003A CALU-002A CAXS-001A CCP-03A CCRS-002A CDP-07A CFT-03A CHEG-005A CHSS-001A CHVH-001A CKIS-003A CKIS-004B CKIS-005A CKOS-001A CKRS-004A CKRS-004B CMM-004B COT-30D COT-32D COT-33D COT-34D COT-35D COT-41D COT-44A COT-52D CSAA-001A CSBP-002A CSCF-003A CSCP-002A CSCS-001A CSCV-001A CSDC-001A CSDE-001A CSFM-001A CSLV-001A CSPV-002A CSSA-001A CSSI-001A CSSL-001A CSSO-001A CSWB-001A CVV-001A TSX-304A TSXF-003I