Singapore HSA registration DE0507934
Neurophet Neurophet AQUA
Singapore·CLASS B·NEUROPHET, Inc.·Registered March 23, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0507934
- Registration Date
- March 23, 2023
- Change Notification Approval Date
- July 07, 2023
- Retention Due Date
- March 22, 2026
Product description
Neurophet AQUA automatically analyze brain images acquired from magnetic resonance imaging (MRI) devices to reconstruct three-dimensional models and quantitatively display the degree of atrophy of the brain by measuring the volume of each cerebral substructure. The software is indicated for use in individuals who are cognitively normal, with or suspected with MCI (mild cognitive impairment), with or suspected with Alzheimer’s disease.
Product Owner
- Name
- NEUROPHET, Inc.
- Short Name
- NEUROPHET, Inc.
- Address
- 12F, 124, Teheran-ro, Gangnam-gu, Seoul, KOREA, REPUBLIC OF
Registrant
- Address
- 300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Model information
- Model Name(s)
- Neurophet AQUA
- Model Identifier(s)
- Neurophet AQUA
About this record
Access comprehensive regulatory information for Neurophet Neurophet AQUA in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507934 and owned by NEUROPHET, Inc.. The device was registered on March 23, 2023.
This page provides complete registration details including product owner information, registrant details, 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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