Data / Medical devices / United States / Alliance Neurodiagnostics, LLC, D/B/A Stratus
Alliance Neurodiagnostics, LLC, D/B/A Stratus: FDA-registered device maker in Irving, TX, United States, 2 510(k) clearances
Alliance Neurodiagnostics, LLC, D/B/A Stratus is registered with the FDA (registration 3027532607) in Irving, TX, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027532607
- Address
- 4545 Fuller Dr Ste 100, Irving, TX, United States, 75038
- Owner or operator
- Alliance Neurodiagnostics, LLC, d/b/a Stratus (10091660)
- Roles
- Complaint file establishment
- First device listed
- October 22, 2024
- Registered through
- 2026
- Brand names listed
- IceCap 2, IceCap 2 Neonate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| March 13, 2025 | K243788 | IceCap product line | GXY | Substantially Equivalent | Bioserenity Medical Devices Group | accessdata.fda.gov |
| January 12, 2023 | K223644 | Neuronaute with IceCap 2 & IceCap 2 Small | GWQ | Substantially Equivalent | Bioserenity | accessdata.fda.gov |
Compare with other makers
Updated March 13, 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.