Data / Medical devices / United States / Medcognetics, Inc
Medcognetics, Inc: FDA-registered device maker in Dallas, TX, United States, 2 510(k) clearances
Medcognetics, Inc is registered with the FDA (registration 3024844299) in Dallas, TX, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024844299
- Address
- 17217 Waterview Parkway Suite 1.202E, Dallas, TX, United States, 75252
- Owner or operator
- MedCognetics, Inc (10086402)
- Roles
- Manufacturer
- First device listed
- November 7, 2022
- Registered through
- 2026
- Brand names listed
- CogNet AI-MT+, QmTRIAGE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | 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 |
|---|---|---|---|---|---|---|
| December 11, 2025 | K252482 | CogNet AI-MT+ | QFM | Substantially Equivalent | Medcognetics, Inc. | accessdata.fda.gov |
| September 29, 2022 | K220080 | CogNet QmTRIAGE | QFM | Substantially Equivalent | Medcognetics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 11, 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.