510(k) Report

FDA applicant

Cortechs Labs, Inc.

San Diego, CA8 decisions2001–20260 recalls

FDA records 8 decisions for Cortechs Labs, Inc. (San Diego, CA) from 2001 to 2026: 8 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Cortechs Labs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12021: 12024: 12026 (partial year): 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cortechs Labs, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cortechs Labs, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological6decisions
  • QIHAutomated Radiological Image Processing Software2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 140 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 118 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170981NeuroQuantCortechs Labs, Inc. · 201714cite it
  • K061855NeuroquantCortechs Labs, Inc. · 20066cite it
  • K210831OnQ NeuroCortechs Labs, Inc. · 20212cite it
  • K241098NeuroQuantCortechs Labs, Inc. · 20241cites it

What has FDA decided for it lately?

  • K261916NeuroQuant PETCortechs Labs, Inc. · 2026
  • K241098NeuroQuantCortechs Labs, Inc. · 2024
  • K210831OnQ NeuroCortechs Labs, Inc. · 2021
  • K170981NeuroQuantCortechs Labs, Inc. · 2017
  • K061855NeuroquantCortechs Labs, Inc. · 2006
  • K032186AutoalignCortechs Labs, Inc. · 2003
  • K021191AutoalignCortechs Labs, Inc. · 2002
  • K012563Deep GrayCortechs Labs, Inc. · 2001

All 8 as Cortechs Labs, Inc. →