Data / Medical devices / Israel / Quantalx Neuroscience
Quantalx Neuroscience: FDA-registered device maker in Kfar Saba Central, Israel, 2 510(k) clearances
Quantalx Neuroscience is registered with the FDA (registration 3020494684) in Kfar Saba Central, Israel. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 20, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020494684
- Address
- 1 Hatachana st., Kfar Saba Central, Israel, 4453001
- Owner or operator
- QuantalX Neuroscience (10094309)
- Roles
- Manufacturer
- First device listed
- November 23, 2025
- Registered through
- 2026
- Brand names listed
- Delphi MCS cap, Delphi Probe, Delphi Software, Delphi Stimulator, Delphi-MD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Non-Invasive Evoked Response Brain Stimulator | SFN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 20, 2025 | DEN250002 | Delphi-MD System | SFN | Unknown | Quantalx Neuroscience, Ltd. | accessdata.fda.gov |
| February 6, 2025 | K243243 | Delphi MCS Electrode Cap | GXY | Substantially Equivalent | Quantalx Neuroscience, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.