Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Cortechs.aiLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list CorTechs Labs with 8 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Aug 12, 2026: NeuroQuant PET.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 12, 2026 | NeuroQuant PETK261916 · LLZ | 510(k) clearances |
| Aug 22, 2024 | NeuroQuantK241098 · QIH | 510(k) clearances |
| Aug 22, 2024 | NeuroQuantK241098 · Radiology | AI-enabled devices |
| Nov 19, 2021 | OnQ NeuroK210831 · QIH | 510(k) clearances |
| Nov 19, 2021 | OnQ NeuroK210831 · Radiology | AI-enabled devices |
| Sep 7, 2017 | NeuroQuantK170981 · LLZ | 510(k) clearances |
| Sep 7, 2017 | NeuroQuantK170981 · Radiology | AI-enabled devices |
| Aug 10, 2006 | NEUROQUANTK061855 · LLZ | 510(k) clearances |
| Oct 14, 2003 | AUTOALIGNK032186 · LLZ | 510(k) clearances |
| Jul 12, 2002 | AUTOALIGNK021191 · LLZ | 510(k) clearances |
| Nov 2, 2001 | DEEP GRAYK012563 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
