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Canon Kalare Diagnostic X-ray System - HSA Registration DE0503682

Access comprehensive regulatory information for Canon Kalare Diagnostic X-ray System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503682 and owned by Canon Medical Systems Corporation. The device was registered on October 01, 2019.

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
DE0503682
Canon Kalare Diagnostic X-ray System
HSA Registration Number: DE0503682
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Product Description

This system is designed for X-ray examinations. It provides physicians with the data required for X-ray diagnosis. This system is appropriate for general radiography/fluoroscopy, gastrointestinal tract (upper and lower parts of the digestive tract), biliary system (examinations in combination with an endoscope such as ERCP (endoscopic retrograde cholangiopancreatography)), orthopedics (contrast imaging such as myelography in which the table is tilted to move the contrast medium using gravity), cardiovascular system (non-vascular IVR or contrast imaging of some vascular systems (abdomen, lower extremity)).

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0503682
Registration Date
October 01, 2019
Retention Due Date
September 30, 2025
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)
Dose-Meter Kit Bucky Slot Cover Diagnostic X-ray System Kalare Diagnostic X-ray System Kalare Diagnostic X-ray System Kalare X-ray Diagnostic Table Image Processor Basic Angio Package DICOM storage commitment service kit DAP Interface Kit Raw data backup kit Media Storage Service Kit FDCF Kit FMEM Kit 1 FMEM Kit 2 MPPS Service Kit MWM Service Kit NTSC Output Kit Pulsed Fluoroscopy Kit REF Monitor Support Kit Diagnostic X-ray Apparatus Beam Limiting Device Lateral Cassette Holder Laser Marker Monitor Cart 1 Monitor Cart 2 Knee Support Pulsed Fluoroscopy Control Unit
Model Identifier(s)
AUA-M4KDK BSC-DUA DREX-KL80/ED DREX-KL80/EE DREX-KL80/EF DUA-450F HDR-08A/S7 HDRK-ANG1 HDRK-COMMIT HDRK-DAP HDRK-DATABK HDRK-DCMDIR HDRK-FDCF HDRK-FMEM/H1 HDRK-FMEM/H5 HDRK-MPPS HDRK-MWM HDRK-NTSC HDRK-PFLU HDRK-REF KXO-80XD TF-10M-3 XACH100A XALM-001A XAMC-100L XAMC-200L XBUA-KNEE XKGC-80XM