# K252563: Neurophet SCALE PET

- Pathway: 510(k) (Traditional)
- Applicant: Neurophet., Inc.
- Decided: May 15, 2026 after 274 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954874 (1996). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221405: Neurophet SCALE PET, Neurophet., Inc. (2022) Summary page 6.
- K252496: Neurophet AQUA AD Plus, Neurophet., Inc. (2026). Cleared while this submission was under review Summary page 6.

## Indications for use
Neurophet SCALE PET is 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 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.

Source page: https://510kreport.com/device/K252563
Methodology: https://510kreport.com/methodology