Data / Medical devices / United States / Cortechs Labs, Inc.
Cortechs Labs, Inc.: FDA-registered device maker in Cov, KY, United States, 6 510(k) clearances
Cortechs Labs, Inc. is registered with the FDA (registration 1226773) in Cov, KY, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1226773
- FEI number
- 3003405980
- Address
- 727 Madison Avenue Suite 29, Cov, KY, United States, 41011
- Owner or operator
- CORTECHS LABS, INC. (9046543)
- Roles
- Manufacturer
- First device listed
- July 6, 2004
- Registered through
- 2026
- Brand names listed
- 3D DISTORTION PHANTOM, CT CoPilot, LesionQuant, NeuroAlign CT, NeuroQuant, NeuroQuant Brain Tumor, NeuroQuant MS, NeuroQuantCT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| Test-Pattern, Radiographic | IXF | 1 | 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 22, 2024 | K241098 | NeuroQuant | QIH | Substantially Equivalent | Cortechs Labs, Inc. | accessdata.fda.gov |
| November 19, 2021 | K210831 | OnQ Neuro | QIH | Substantially Equivalent | Cortechs Labs, Inc. | accessdata.fda.gov |
| November 19, 2019 | K191278 | RSI-MRI+ | LLZ | Substantially Equivalent | Multimodal Imaging Services Corporation (Dba Healthlytix) | accessdata.fda.gov |
| September 7, 2017 | K170981 | NeuroQuant | LLZ | Substantially Equivalent | Cortechs Labs, Inc. | accessdata.fda.gov |
| December 7, 2016 | K161322 | CT CoPilot | LLZ | Substantially Equivalent | Zepmed, LLC | accessdata.fda.gov |
| August 10, 2006 | K061855 | NEUROQUANT | LLZ | Substantially Equivalent | Cortechs Labs, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Test-Pattern, Radiographic
- All makers of Automated Radiological Image Processing Software
Updated August 22, 2024. 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.