Neurophet Neurophet SCALE PET
- Registration number
- DE0510480
- Model name
- Neurophet SCALE PET
- Model identifier
- Neurophet SCALE PET
- Registration date
- March 20, 2025
- Risk class
- Class B
- Product owner
- NEUROPHET, Inc.
- Registrant / registration holder
- ANDAMAN MEDICAL PTE. LTD.
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 address
- 12F, 124, Teheran-ro, Gangnam-gu, Seoul, Korea, South
- Registrant address
- 300 TAMPINES AVENUE 5, #09-02, INCOME AT TAMPINES JUNCTION, Singapore 529653
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.