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Singapore HSA registration DE0510480

Neurophet Neurophet SCALE PET

Singapore flagSingapore·CLASS B·NEUROPHET, Inc.·Registered March 20, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0510480
Registration Date
March 20, 2025
Retention Due Date
March 19, 2026
Product description
Neurophet SCALE PET is software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI, CT and PET. The software aids clinician in the assessment and quantification of pathologies from PET scans of the human brain. It enables automatic analysis and visualization of brain PET through the calculation of standard uptake volume ratios (SUVR) and its derived quantitative values within target regions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations. This system is a diagnostic aid to assist physicians with analyzing the patient’s brain images and diagnose degenerative brain diseases including Alzheimer’s disease and mild cognitive impairment.
Product Owner
Name
NEUROPHET, Inc.
Short Name
NEUROPHET, Inc.
Address
12F, 124, Teheran-ro, Gangnam-gu, Seoul, KOREA, REPUBLIC OF
Registrant
Name
ANDAMAN MEDICAL PTE. LTD.
Address
300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Model information
Model Name(s)
Neurophet SCALE PET
Model Identifier(s)
Neurophet SCALE PET
About this record

Access comprehensive regulatory information for Neurophet Neurophet SCALE PET in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510480 and owned by NEUROPHET, Inc.. The device was registered on March 20, 2025.

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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