# Cortechs Labs, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 8 (2001–2026): 8 510(k) clearances
- Product codes: LLZ (6), QIH (2)
- 510(k) review time since 2016: median 140 days, against 118 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 23 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)
- Vital Images, Inc.: 1 (https://510kreport.com/company/vital-images)
- Combinostics OY: 1 (https://510kreport.com/company/combinostics)

## Firms that cite its devices most
- Neurophet., Inc.: 2 (https://510kreport.com/company/neurophet)
- Brainreader Aps: 1 (https://510kreport.com/company/brainreader)
- Zepmed, LLC: 1 (https://510kreport.com/company/zepmed)
- Neurospectrum Insights Corp.: 1 (https://510kreport.com/company/neurospectrum-insights)
- Terran Biosciences, Inc.: 1 (https://510kreport.com/company/terran-biosciences)
- Corticometrics, LLC: 1 (https://510kreport.com/company/corticometrics)
- Combinostics OY: 1 (https://510kreport.com/company/combinostics)
- Pixyl SA: 1 (https://510kreport.com/company/pixyl)

## Its most-cited devices
- K170981: NeuroQuant (2017), cited by 14
- K061855: Neuroquant (2006), cited by 6
- K210831: OnQ Neuro (2021), cited by 2
- K241098: NeuroQuant (2024), cited by 1

## Recent decisions
- K261916: NeuroQuant PET (Aug 12, 2026)
- K241098: NeuroQuant (Aug 22, 2024)
- K210831: OnQ Neuro (Nov 19, 2021)
- K170981: NeuroQuant (Sep 7, 2017)
- K061855: Neuroquant (Aug 10, 2006)
- K032186: Autoalign (Oct 14, 2003)
- K021191: Autoalign (Jul 12, 2002)
- K012563: Deep Gray (Nov 2, 2001)

Source page: https://510kreport.com/company/cortechs-labs