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Canon Alphenix Interventional Angiography System INFX-8000C - HSA Registration DE0502894

Access comprehensive regulatory information for Canon Alphenix Interventional Angiography System INFX-8000C in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502894 and owned by Canon Medical Systems Corporation. The device was registered on March 15, 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
DE0502894
Canon Alphenix Interventional Angiography System INFX-8000C
HSA Registration Number: DE0502894
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Product Description

Intended for multidirectional observation of the flow of contrast medium injected into the blood vessels of a patient. Cardiac system is designed for selective cardiac angiography (with catheterization). This system is intended for use in interventional procedures for cardiac vessels, such as PCI, and also for use in EP (electrophysiological) studies. Vascular system is designed for selective angiography (with catheterization) of the head, abdomen, and lower extremities. This system is intended for use in interventional procedures, such as embolization, for blood vessels in the head, abdomen, and lower extremities.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0502894
Registration Date
March 15, 2019
Change Notification Approval Date
April 21, 2025
Retention Due Date
March 14, 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)
Beam Limiting Device Beam Limiting Device Beam Limiting Device System cabinet Corner cover Side cover Diagnostic X-ray Apparatus Diagnostic X-ray Apparatus Diagnostic X-ray Apparatus Catheterization table Catheterization table Catheterization table Catheterization table Catheterization table Catheterization table LCD monitor LCD monitor Digital Radiography System X-ray tube assembly X-ray tube assembly X-ray tube assembly X-ray tube assembly X-ray tube assembly INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix Monitor suspension for four LCD monitors Monitor suspension for six LCD monitors Monitor suspension for 58"LCD Monitor INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix Rack for Chiller and HEX Large-screen monitor rack X-Ray Flat Panel Detector X-Ray Flat Panel Detector X-Ray Flat Panel Detector X-Ray Flat Panel Detector X-Ray Flat Panel Detector UPS Connection Kit Satellite Tablet Console Table Side Tablet Console Satellite Tablet Console Table Side Tablet Console Arm cover Accessories table rail Arm rest Arm rest Arm support Base plate Drape holder Extension rails Extension tabletop Extension Tabletop for CAT-860B/B1 Extension Tabletop for CAT-880B/CT Free-slide grip for CAT (mushroom SW) Tabletop control console Foot switch Wireless footswitch Hand grip Hand grip Head-end table control switch kit Longitudinal Sensor unit OR Table kit OR Table kit KIT FOR OR TABLE COMBINATION KIT FOR OR TABLE COMBINATION Stepping unit for catheterization table(factory option) Tabletop mat Tabletop mat Satellite console Tableside console Satellite console Tableside console for CAS-930A Ceiling rails Ceiling rails Ceiling rails for CAS-930A Ceiling rails for CAS-930A Ceiling rails Ceiling rails Ceiling rails Modificaton Kit Modificaton Kit Modificaton Kit Modificaton Kit Modificaton Kit Modificaton Kit Modification Kit Modification Kit Modification Kit Modification Kit Ceiling height adjustment kit Ceiling height adjustment kit Extended lateral rails for monitor suspension Magnetic shielding kit Magnetic shielding kit Magnetic shielding kit Stylish Design Cover Stylish Design Cover Table I/F Kit Tilting Table I/F kit Tilting Table I/F kit Table I/F Kit 3D-angio application software Angio Workstation monitor kit Angio Workstation additional monitor kit Rocket Link Connection Kit Fibre Channel Connection Kit Angio Workstation Deep Learning Server External signal display kit Footswitch for fluoroscopy GPU Kit Keyboard kit Large monitor Accessory Kit 2 Large monitor Accessory Kit 2 Main console C Microphone kit Integrated monitor accessory kit Integrated monitor accessory kit for extension Power ON switch box 3D Viewer kit 3D Viewer kit Additional reference monitor Review console Stepping DSA kit Area dose meter ion chamber Area dose meter ion chamber Area dose meter Upgrade kit of integrated monitor Large-screen monitor Large-screen monitor Encorder for Large screen monitor Digital Encoder 1 Digital Encoder 2 Monitor integration system Monitor integration system Diagnostic X-ray Apparatus
Model Identifier(s)
BLA-900A BLA-900A/R1 BLA-900C CAB-100B CABC-100B CABS-100B CAS-830B/B1 CAS-930A CAS-930A/F1 CAT-850B/B1 CAT-860B/B1 CAT-880B/B1 CAT-880B/CT CAT-880B/F1 CAT-880B/FC CDL2013A-1A CL19196 DFP-8000C/A2 DSRX-T7345GFS DSRX-T7444GDS DSRX-T7445GFS DSRX-T7634GFS DSRX-T7735GFS INFX-8000C/Y1 INFX-8000C/Y3 INFX-8000C/Y5 INFX-8000C/Y8 INFX-8000C/Y9 INFX-8000C/YE INFX-8000C/YF INFX-8000C/YH INFX-8000C/Z1 INFX-8000C/Z5 INFX-8000C/ZE INFX-8000C/ZJ INFX-8000C/ZL INFX-8000C/ZN INFX-8000C/ZQ INFX-8000C/ZT INFX-8000C/ZU INFX-8000C/ZW INFX-8000C/ZX INFZX-8000C/ZY MSF-04A/B1 MSF-06A/B1 MSF-56A/B1 NFX-8000C/Z3 RAC-100C RAC-100L TFP-1200A/C1 TFP-1200C/A1 TFP-1216A/C1 TFP-1216C/A1 TFP-800A/C1 XABT-UPS804 XACP-001AA/C1 XACP-001BA/C1 XACP-002AA/C1 XACP-002BA/C1 XBAC-001A XBAM-001A XBAR-001A XBAR110A XBAS-001A XBBP250B XBDB-001A XBER-001A XBET-001A XBET-860B/B1 XBET-880B/CT XBFG-001A/B1 XBFG-850B/B1 XBFS-880S XBFS-880WS XBHG-001A/B1 XBHG-002A/B1 XBHR-001A/B1 XBLS-850B XBOR-830B/B1 XBOR-830C/B1 XBOR-930A/F1 XBOR-930B/F1 XBSD-850B XBTM-001A XBTM-002A XGCP-880AA/B1 XGCP-880BA/B1 XGCP-930AA XGCP-930BA XGCR-040B XGCR-040B/F1 XGCR-050B XGCR-050B/F1 XGCR-060B XGCR-060B/B1 XGCR-060B/F1 XGCT-830C/B1 XGCT-830D/B1 XGCT-830E/B1 XGCT-930A XGCT-930B XGCT-930B/F1 XGCT-930C XGCT-930C/2R XGCT-930C/F1 XGCT-930C/FR XGHA-001A XGHA-002A XGMR-MSF021/B1 XGPA-1200A XGPA-1216A XGPA-800A XGSD-088H/B1 XGSD-120H/B1 XGTP-930A XGTT-830A XGTT-830A/CT XGTT-930A XIDF-3DI801 XIDF-AMK801 XIDF-AMK803/A1 XIDF-AWK801 XIDF-AWK802 XIDF-AWS801/B4 XIDF-DLS801/A1 XIDF-ESD801/A1 XIDF-FS801S XIDF-GPU801 XIDF-KBD802/EN XIDF-LMA802/C1 XIDF-LMA802/CS XIDF-MCC80S XIDF-MIC802 XIDF-MISA/A2 XIDF-MISW XIDF-PON801 XIDF-PVG801/A1 XIDF-PVG801/B1 XIDF-REF801/C1 XIDF-RVC801 XIDF-STP801 XJDC-009A XJDC-016A XJDK-001A/V9 XMEZ-COMUP XMEZ-LMM021/A2 XMEZ-LMM021/A3 XMEZ-LMMENC/A1 XMEZ-LMMENC/D1 XMEZ-LMMENC/D2 XMEZ-MISD/A1 XMEZ-MISM/A1 XTP-8100XG