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Canon Alphenix Interventional Angiography System, INFX-8000H - HSA Registration DE0503754

Access comprehensive regulatory information for Canon Alphenix Interventional Angiography System, INFX-8000H in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503754 and owned by Canon Medical Systems Corporation. The device was registered on October 22, 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
DE0503754
Canon Alphenix Interventional Angiography System, INFX-8000H
HSA Registration Number: DE0503754
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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
DE0503754
Registration Date
October 22, 2019
Retention Due Date
October 21, 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)
Beam Limiting Device System cabinet Cabinet corner cover Cabinet side cover Diagnostic X-ray Apparatus Diagnostic X-ray Apparatus Digital Radiography System INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix INTERVENTIONAL ANGIOGRAPHY SYSTEM Alphenix Monitor suspension Monitor suspension Monitor suspension Rack for Chiller and HEX Rack for Large Screen Monitor X-Ray Flat Panel Detector X-Ray Flat Panel Detector UPS Connection Kit Foot switch Kit for OR-table combination Kit for OR-table combination Kit for OR-table combination Kit for OR-table combination Satellite console Satellite console Ceiling rails Ceiling height adjustment kit Ceiling height adjustment kit Lateral rails for flat panel monitor suspension Magnetic shielding kit Magnetic shielding kit 3D Angio kit 3D Roadmap kit Multi-Modality Roadmap kit(CT,MR) Angio Workstation monitor kit Angio Workstation additional monitor kit Angio Workstation Cerebral Aneurysm Analysis Kit Dose tracking system kit External signal display kit Fluoroscopy footswitch in the control room keyboard Kit Low contrast imaging kit Large monitor Accessory Kit 2 Large monitor Accessory Kit 2 Main console C Microphone kit Multi Language(German) kit Multi Language(Spanish) kit Multi Language(French) kit Multi Language(Italian) kit Multi Language(Portuguese) kit Multi Language(Russian) kit Power ON switch box 3D Viewer Kit Basic kit for clinical analysis application IV-LINQ kit Basic kit for Clinical Analysis Application QCA Kit QVA Kit LVA Kit RVA kit 3D QCA Kit Stent Enhancer Kit Additional reference monitor kit Rotational DSA kit Review console Spot fluoroscopy kit Dynamic Device Stabilizer Kit TAVR Support Kit1 TAVR Support Kit3 Mitral analysis for TAVR Support Kit Left Atrium Appendage Analysis for TAVR Support Kit Regurgitation Analysis for TAVR Support Kit Embolization Plan Kit Area dose meter ion chamber Area dose meter Large-screen monitor Large-screen monitor Digital Encoder 1 Digital Encoder 2 Diagnostic X-ray Apparatus
Model Identifier(s)
BLA-900A CAB-100B CABC-100B CABS-100B CAS-830B/B1 CAS-930A DFP-8000C/A1 INFX-8000H/Y3 INFX-8000H/Y5 INFX-8000H/YE MSF-04A/B1 MSF-06A/B1 MSF-56A/B1 RAC-100C RAC-100L TFP-1200A/C1 TFP-1216A/C1 XABT-UPS804 XBFS-880S XBOR-830B/B1 XBOR-830C/B1 XBOR-930A XBOR-930B XGCP-880AA/B1 XGCP-930AA XGCR-050B XGHA-001A XGHA-002A XGMR-MSF021/B1 XGPA-1200A XGPA-1216A XIDF-3DI801 XIDF-3DP802/B1 XIDF-3DP804 XIDF-AMK801 XIDF-AMK803 XIDF-AWS801/B2 XIDF-CAA801 XIDF-DTS802/B2 XIDF-ESD801 XIDF-FS801S XIDF-KBD802/EN XIDF-LCI801 XIDF-LMA802/C1 XIDF-LMA802/CS XIDF-MCC80S XIDF-MIC802 XIDF-MLDE01 XIDF-MLES01 XIDF-MLFR01 XIDF-MLIT01 XIDF-MLPT01 XIDF-MLRU01 XIDF-PON801 XIDF-PVG801 XIDF-QCA700 XIDF-QCA708 XIDF-QCA850 XIDF-QCA851 XIDF-QCA852 XIDF-QCA853 XIDF-QCA855 XIDF-QCA856 XIDF-QCA857 XIDF-REF801/C1 XIDF-ROT801 XIDF-RVC801 XIDF-SFL801 XIDF-STA801 XIDF-TAV801/A1 XIDF-TAV803/A1 XIDF-TAV804/A1 XIDF-TAV805/A1 XIDF-TAV806/A1 XIDF-TCE801 XJDC-016A XJDK-001A/V8 XMEZ-LMM021/A2 XMEZ-LMM021/A3 XMEZ-LMMENC/D1 XMEZ-LMMENC/D2 XTP-8100XG