Cortechs Labs, Inc.: FDA clearances and approvals
Cortechs Labs, Inc. has 8 FDA 510(k) clearances (first 2001, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 88 days. Since 2017 its median was 140 days, against 131 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 157 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 245 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 122 |
| 2025 | 0 | — |
| 2026 | 1 | 64 |
Review time against the same product codes
Since 2017, Cortechs Labs, Inc.'s cleared 510(k)s took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
Review panels
- Radiology (8)
Most recent Cortechs Labs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261916 | NeuroQuant PET | LLZ | 2026-08-12 | 64 |
| K241098 | NeuroQuant | QIH | 2024-08-22 | 122 |
| K210831 | OnQ Neuro | QIH | 2021-11-19 | 245 |
| K170981 | NeuroQuant | LLZ | 2017-09-07 | 157 |
| K061855 | NEUROQUANT | LLZ | 2006-08-10 | 41 |
| K032186 | AUTOALIGN | LLZ | 2003-10-14 | 89 |
| K021191 | AUTOALIGN | LLZ | 2002-07-12 | 88 |
| K012563 | DEEP GRAY | LLZ | 2001-11-02 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Cortechs Labs, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cortechs Labs, Inc. have?
Cortechs Labs, Inc. has 8 FDA 510(k) clearances (first 2001, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Cortechs Labs, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cortechs Labs, Inc.'s cleared 510(k)s is 88 days. Since 2017: 140 days, versus 131 days for all cleared 510(k)s in the same product codes.
What devices does Cortechs Labs, Inc. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 6); QIH (Automated Radiological Image Processing Software, 2).
Has Cortechs Labs, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cortechs Labs, Inc. Related entities may recall under other names.
Next steps
- See all 8 Cortechs Labs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Cortechs Labs, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.