Singapore HSA registration DE0506156
FUJIFILM ECHELON Smart MRI System
Singapore·CLASS B·FUJIFILM CORPORATION·Registered September 10, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0506156
- Registration Date
- September 10, 2021
- Change Notification Approval Date
- September 05, 2024
- Retention Due Date
- September 09, 2025
Product description
The ECHELON Smart is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the head and body. The images produced reflect the spatial distribution of protons (Hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
Product Owner
- Short Name
- FUJIFILM
- Address
- 26-30 nishiazabu 2 chome, MINATO-KU TOKYO 106-8620 JAPAN, JAPAN
Registrant
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
- Model Name(s)
- ECHELON Smart MRI System Gating function package Breast coil P 3inch coil 9inch coil Breast coil CTL Spine coil Foot & Ankle coil Flex Body coil Flex Body upper coil GP Flex coil Head & Neck coil Knee coil Shoulder coil WIT Spine coil Wrist coil
- Model Identifier(s)
- ECHELON Smart MR-EM-7 MR-IBC-153B MR-T3IN-153B MR-T9IN-153B MR-TBT-153B MR-TCTL-153B MR-TFA-153B MR-TFB-153B MR-TFBU-153B MR-TGP-153B MR-THN-153B MR-TKE-153B MR-TSD-153B MR-TSP-153B MR-TWT-153B
About this record
Access comprehensive regulatory information for FUJIFILM ECHELON Smart 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 DE0506156 and owned by FUJIFILM CORPORATION. The device was registered on September 10, 2021.
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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