Singapore HSA registration DE0503682
Canon Kalare Diagnostic X-ray System
Singapore·CLASS C·Canon Medical Systems Corporation·Registered October 01, 2019Device 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 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)).
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
About this record
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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