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Canon Vantage Orian MRI System - HSA Registration DE0502777

Access comprehensive regulatory information for Canon Vantage Orian MRI System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502777 and owned by Canon Medical Systems Corporation. The device was registered on February 12, 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 B
DE0502777
Canon Vantage Orian MRI System
HSA Registration Number: DE0502777
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Product Description

Vantage Orian 1.5T system is indicated for use as a diagnostic imaging modality that produces cross sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non contrast enhanced imaging, such as MRA.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0502777
Registration Date
February 12, 2019
Change Notification Approval Date
July 21, 2023
Retention Due Date
February 11, 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)
Patient Pads for Spine and Extremities Atlas SPEEDER Body 32ch Cardiac SPEEDER Pediatric SPEEDER Shape Coil Shape Coil W Octave SPEEDER Head Atlas SPEEDER Head/Neck Wrist SPEEDER Shoulder SPEEDER Extra Large Knee Array Coil 4ch Flex SPEEDER 16ch Flex SPEEDER Medium 16ch Flex SPEEDER Large 16ch Tx/Rx Knee SPEEDER Knee/ Foot SPEEDER Breast SPEEDER (8ch package) Breast SPEEDER (4ch package) Breast SPEEDER CX Adaptive Endo Pelvis SPEEER Atlas SPEEDER Spine Octave SPEEDER Spine Coil Holder for TMJ Imaging Flex Breast SPEEDER Breast Riser kit Breast Grid 16ch Flex SPEEDER Pad Kit Patient Adaptable Tilting Device Breast Riser CX MSK SPEEDER Package Breast Loop kit ฯ†70 Flex Coil ฯ†100 Flex Coil ฯ†100 Flex Coil ฯ†150 Flex Coil ฯ†150 Flex Coil ฯ†200 Flex Coil QD Head Coil T/R Coil Hardware Kit Second Console Second Console Second Console Foot Switch Unit Receiving Circuit Extension Kit Receiving Circuit Extension Kit Wireless Cardiac Gating System Wireless Peripheral Pulse and Respiratory Gating Package Additional patient CAMERA package Vantage Orian Main Unit Main Unit Main Unit Main Unit Main Unit Main Unit Main Unit Main Unit mBody Package mBreast Package Cardiac Analysis Application mCardiac Package Contrast Free MRA Application Olea NovaTM+ Sequence mCardiac plus Package Compressed SPEEDER Application Compressed SPEEDER Application-3D DICOM Storage Commitment Kit DICOM MPPS SCU Kit DICOM Q/R SCP Kit DICOM Q/R SCU Kit Advanced intelligent Cleare-IQ Engine for MR DTI Application DTT Application EasyTech Cardiac Elite Package EasyTech Elite Package Fast 3D Package Fat Fraction Quantification Application Fast 3D for mVox Fast 3D for TOF Fast 3D for SSFP GAIN Algorithm k-t SPEEDER Application EasyTech Cardiac Package EasyTech Knee Package NeuroLine+ Application SpineLine+ Application System Software System Software System Software Multi Voxel MRS Application Single Voxel MRS Application/ MRS Application for Second Console mNeuro Package mOrtho Package Quiet and Quick Clinical Applications Package MultiBand SPEEDER Application Quick Star Application UTE Application mVascular Package Pianissimo Zen Application Ceiling Camara Cabinet sound insulating kit Patient Pads for Octave SPEEDER coils AiCE Reconstruction Processing Unit for MR Advanced Image Reconstruction Unit Advanced Image Reconstruction Unit MR Elastography Gantry Ambient Lighting Gantry Ambient Lighting Gantry Ambient Lighting/Green Gantry Ambient Lighting/Pink Gantry Ambient Lighting/White Gantry Ambient Lighting/Yellow Higher Order Shim Kit Software Upgrade Package (V6.0) for Vantage Orian Software Upgrade Package (V7.0) for Vantage Orian Extended Table Travel Option Extended Table Travel Option Extended Table Travel Option Dockable Table Dockable Table Dockable Table Ceiling Camera Package MR Theater MR Theater MR Theater Apps for Tablet UX Trench Routing Kit Trench Routing Kit Uninterruptible Power-supply System Kit
Model Identifier(s)
MBPP-1503/S1 MJAB-167A MJAB-187A MJAB-197A MJAB-207A MJAB-217A MJAH-167A MJAH-177A MJAJ-167B MJAJ-177A MJAJ-187A MJAJ-197A MJAJ-217A MJAJ-227A MJAJ-237A MJAJ-257A MJAM-127A/S1 MJAM-127A/S2 MJAM-147A MJAP-117A MJAS-147A MJAS-167A MJCA-147A/S2 MJCA-177A/S1 MJCA-187A MJCA-197A MJCA-207A MJCA-227A MJCA-247A MJCG-307A MJKM-107A MJLC-077G MJLC-107G MJLC-107H MJLC-157G MJLC-157H MJLC-207G MJQH-147A MJTX-107A MKDN-013A/S2 MKDN-013B/S2 MKDN-014A/S2 MKFS-003A/S1 MKPA-1508/S1 MKPA-1508/S3 MKSU-ECGU13/S1 MKSU-PRGK13/S1 MMPM-GP3001/S1 MRT-1550 MRT-1550/PA MRT-1550/PF MRT-1550/PI MRT-1550/PN MRT-1550/S1 MRT-1550/SA MRT-1550/SI MRT-1550/SN MSSW-BODY3 MSSW-BRST3 MSSW-CAAS2 MSSW-CFA3 MSSW-CFMRA3 MSSW-CNV MSSW-CPP1 MSSW-CS01 MSSW-CS3D1 MSSW-DCCOU1 MSSW-DCPPU1 MSSW-DCQRP1 MSSW-DCQRU1 MSSW-DLR1 MSSW-DTI2 MSSW-DTT MSSW-ETCEP1/S1 MSSW-ETEP1/S1 MSSW-F3DP MSSW-FIQ1 MSSW-FST3D MSSW-FST3D2 MSSW-FST3D3 MSSW-GA01 MSSW-KTS1 MSSW-LOCCA4 MSSW-LOCKP MSSW-LOCNU2 MSSW-LOCSP1 MSSW-MP45A/S1 MSSW-MP60C/S1 MSSW-MP70A/S1 MSSW-MRSM2 MSSW-MRSS2 MSSW-NEURO2 MSSW-ORTHO MSSW-QQCAP1/S1 MSSW-SMS1 MSSW-SOS1 MSSW-UTE MSSW-VASCU MSSW-ZEN MZCK-0001/S2 MZCL-1550/S1 MZCM-1501 MZDL-010A/S1 MZDL-010B/S1 MZDL-011B MZEK-001A MZGL-1502/S1 MZGL-1503 MZGL-GN01/S1 MZGL-PK01/S1 MZGL-WT01/S1 MZGL-YE01/S1 MZKT-HOSK14 MZKT-MP1522/S4 MZKT-MP1532 MZPT-1550/S1 MZPT-1551 MZPT-1552 MZPT-1560/S1 MZPT-1560/S2 MZPT-1560/S4 MZTC-001A/S2 MZTH-4001/S1 MZTH-4003 MZTH-4004 MZTK-001A MZTR-1501/S1 MZTR-1503/S1 MZUP-001A