Neurophet Neurophet SCALE PET - HSA Registration DE0507567
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 DE0507567 and owned by NEUROPHET, Inc.. The device was registered on December 02, 2022.
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.
Neurophet SCALE PET is a software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI and PET. The software aids clinician in the assessment and quantification of pathologies from PET Amyloid/FDG scans of the human brain. It enables automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR) 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. The device should only be used as an adjunct tool and not a sole determinant for diagnosis of MCI (mild cognitive impairment) and Alzheimer’s disease only.