# DEN250002: Delphi-MD System

- Pathway: De Novo (Direct)
- Applicant: Quantalx Neuroscience, Ltd.
- Decided: Aug 20, 2025 after 229 days
- Product code: SFN (Non-Invasive Evoked Response Brain Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Delphi-MD System is intended to elicit, amplify, record, and display brain evoked potentials to transcranial magnetic stimulation (TEPs) of the left and right primary motor cortex, dorsolateral prefrontal cortex, and primary visual cortex. The device is also intended to analyze TEPs and provide quantitative output parameters of the evoked response including the TEP waveform, global mean field potential, local mean field potential distribution maps, quantify amplitudes and latencies of the response, and present the output parameters compared to a normative reference database. The normative reference database age range is limited to 50-75 years of age. The Delphi-MD System is not to be relied on solely to make or confirm a diagnosis.

Source page: https://510kreport.com/device/DEN250002
Methodology: https://510kreport.com/methodology