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Singapore HSA registration DE0506994

Fujifilm OASIS Velocity MR Imaging System

Singapore flagSingapore·CLASS B·FUJIFILM CORPORATION·Registered June 23, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0506994
Registration Date
June 23, 2022
Change Notification Approval Date
September 05, 2024
Retention Due Date
June 22, 2025
Product description
This equipment is the MR imaging system using the super conductive magnet and is used for the purpose of whole body imaging diagnosis covering from central nerve system to orthopedic field.
Product Owner
Name
FUJIFILM CORPORATION
Short Name
FUJIFILM
Address
26-30 nishiazabu 2 chome, MINATO-KU TOKYO 106-8620 JAPAN, JAPAN
Registrant
Name
FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
Name
FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
Model Name(s)
SENSE unit WIT Head attachment WIT Torso coil A WIT Torso coil B WIT Head/Neck attachment WIT Neck Attachment Gating function package (ECG, Peripheral, Respiratory) Filter box GPA unit Foot/Ankle coil Breast coil IRCP unit Multipurpose coil MCU unit Micro coil Operator’s console WIT Spine coil WIT Posterior Head/Neck coil Large Flex coil Extra large Flex coil Extremity coil Shoulder coil Wrist coil Patient table Gantry OASIS Velocity
Model Identifier(s)
ME-EX-10 MR-ABA-123 MR-ABC-123A MR-ABC-123B MR-AHA-123 MR-ANA-123 MR-EM-7 MR-FL-M3 MR-GPA-1501MT MR-HRF-123 MR-IBC-123 MR-IRCP-M3 MR-JCR-123 MR-MCU3-120 MR-MIC-123 MR-OP-160PH MR-PBC-123 MR-PHC-123 MR-QFC-123 MR-QFC-123XL MR-RKC-123 MR-RSC-123 MR-RWC-123 MR-TB-123 MR-WS-123 OASIS
About this record

Access comprehensive regulatory information for Fujifilm OASIS Velocity MR Imaging 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 DE0506994 and owned by FUJIFILM CORPORATION. The device was registered on June 23, 2022.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B