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CANON Alphenix Interventional Angiography System, INFX-8000V - HSA Registration DE0502979

Access comprehensive regulatory information for CANON Alphenix Interventional Angiography System, INFX-8000V in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502979 and owned by Canon Medical Systems Corporation. The device was registered on April 08, 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
DE0502979
CANON Alphenix Interventional Angiography System, INFX-8000V
HSA Registration Number: DE0502979
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Product Description

INFX-8000V systems are diagnostic X-ray systems designed for multidirectional observation of the flow of contrast medium injected into the blood vessels of a patient. Two system types, single-plane (SP) and biplane (BP), are available. The SP system uses one support unit in combination and performs fluoroscopy/radiography of the target region from one direction. The BP system uses two support units in combination and performs fluoroscopy/radiography of the target region from two directions. In addition, two types are available for both the SP and BP systems according to the intended examination: for selective angiography (catheterization) of the heart (cardiac configuration) and for selective angiography (catheterization) of the head, abdomen, and lower extremities (vascular configuration).

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0502979
Registration Date
April 08, 2019
Change Notification Approval Date
August 26, 2024
Retention Due Date
April 07, 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)
X-ray beam limiting device X-ray beam limiting device System cabinet Cabinet corner cover Cabinet side cover ฮฉ-arm support C arm support unit Catheterization table Catheterization table Digital radiography system 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 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 eight LCD monitors Monitor suspension for 58" LCD monitors Rack for Chiller and HEX Rack for Large Screen Monitor Flat Panel Detector Flat Panel Detector Flat Panel Detector X-ray Flat Panel Detector Flat Panel Detector UPS Connection Kit Satellite Tablet Console Table Side Tablet Console Satellite Tablet Console Table Side Tablet Console V9 Upgrade kit V9 Upgrade kit Arm cover Accessory tabletop rail Arm rest Arm rest Arm Support Base plate for CAT-850B Drape holder Extension rails Extension tabletop Tabletop control switch Tabletop control console Foot switch Wireless footswitch๏ผˆfor BiPlane) Foot switch Foot switch Wireless footswitch๏ผˆfor BiPlane) Wireless foot switch Hand grip Hand grip Head-end table control switch kit Table Longitudinal Sensor Kit Stepping DSA support kit Tabletop mat Tabletop mat Base plate for CAS-880A Base plate for CAS-880Aใ€€ Cable outlet opposite side kit Satellite console Tableside console Tableside console Satellite console Tableside console Tableside console Floor-arm optical sensor cover option Monitor Suspension Rail Extended Lateral Rails for Monitor Suspention Magnetic shielding kit Magnetic shielding kit Magnetic shielding kit Support column rotation lock kit 3D angiography kit AngioWorkstation Monitor Kit AngioWorkstation Additional Monitor Kit Rocket Link Connection Kit Fibre Channel Connection Kit Angio Workstation Angio Workstation Biplane system kit 3 Biplane system kit 4 External signal display kit Fluoroscopy footswitch for the control room Fluoroscopy footswitch for the control room GPU kit Keyboard kit Large monitor accessory Kit2 Main console C Main console C Microphone kit Integrated monitor accessory kit Integrated monitor accessory kit for extension 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 3D Viewer kit Additional reference monitor kit Additional reference monitor kit2 Review console Stepping DSA kit Dose chamber Dose chamber Dose area product meter Dose area product meter Upgrade kit of integrated monitor Large-screen monitor Encoder for Large Screen Monitor Monitor integration system Monitor integration system Software Upgrade kit X-ray generator
Model Identifier(s)
BLA-900A BLA-900C CAB-100B CABC-100B CABS-100B CAS-820B/B1 CAS-880A/B2 CAT-850B/B1 CAT-880B/B1 DFP-8000C/A2 DSRX-T7634GFS INFX-8000V/Y1 INFX-8000V/Y3 INFX-8000V/Y5 INFX-8000V/Y7 INFX-8000V/Y9 INFX-8000V/YB INFX-8000V/YD INFX-8000V/YF INFX-8000V/YH INFX-8000V/YK INFX-8000V/YM INFX-8000V/YP INFX-8000V/YR INFX-8000V/YT INFX-8000V/YV INFX-8000V/YX INFX-8000V/Z1 INFX-8000V/Z3 INFX-8000V/Z5 INFX-8000V/Z7 INFX-8000V/Z9 INFX-8000V/ZB INFX-8000V/ZD INFX-8000V/ZF INFX-8000V/ZH INFX-8000V/ZK INFX-8000V/ZM INFX-8000V/ZP MSF-04A/B1 MSF-06A/B1 MSF-08A/B1 MSF-56A/B1 RAC-100C RAC-100L TFP-1200A/C1 TFP-1200C/A1 TFP-1216A/C1 TFP-1216C/A1 TFP-800A/C1 XABT-UPS804 XACP-001AA XACP-001BA XACP-002AA XACP-002BA XAGU-HDKIT2/B1 XAGU-HDKIT2/S1 XBAC-001A XBAM-001A XBAR-001A XBAR110A XBAS-001A XBBP250B XBDB-001A XBER-001A XBET-001A XBFG-001A/B1 XBFG-850B/B1 XBFS-1000M XBFS-1000WM XBFS-880B XBFS-880S XBFS-880WB XBFS-880WS XBHG-001A/B1 XBHG-002A/B1 XBHR-001A/B1 XBLS-850B XBSD-850B XBTM-001A XBTM-002A XGBP-880A XGBP-880B XGCO-820A/B1 XGCP-880AA XGCP-880BA/B1 XGCP-880BA/TA XGCP-882AA/B1 XGCP-882BA/B1 XGCP-882BA/TA XGFC-880A/H1 XGMR-012A XGMR-MSF021/B1 XGPA-1200A XGPA-1216A XGPA-800A XGSL-880A XIDF-3DI801 XIDF-AMK801 XIDF-AMK803 XIDF-AWK801 XIDF-AWK802 XIDF-AWS801 XIDF-AWS801/B4 XIDF-BPS803/C1 XIDF-BPS804/C1 XIDF-ESD801 XIDF-FS801B XIDF-FS801S XIDF-GPU801 XIDF-KBD802/EN XIDF-LMA802 XIDF-MCC80B XIDF-MCC80S XIDF-MIC802 XIDF-MISA/A2 XIDF-MISW XIDF-MLDE01 XIDF-MLES01 XIDF-MLFR01 XIDF-MLIT01 XIDF-MLPT01 XIDF-MLRU01 XIDF-PON801 XIDF-PVG801/A1 XIDF-PVG801/B1 XIDF-REF801/C1 XIDF-REF802/C1 XIDF-RVC801 XIDF-STP801 XJDC-009A XJDC-016A XJDK-001A/V9 XJDK-002A/V9 XMEZ-COMUP XMEZ-LMM021 XMEZ-LMMENC XMEZ-MISD/A1 XMEZ-MISM/A1 XSGS-VL009A/B2 XTP-8100XG