Software Nemotec S.L.: FDA clearances and approvals
Software Nemotec S.L. has 5 FDA 510(k) clearances (first 2019, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time: 135 days. Since 2017 its median was 135 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 |
|---|---|---|
| 2019 | 1 | 84 |
| 2020 | 2 | 224 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 90 |
| 2024 | 1 | 135 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Software Nemotec S.L.'s cleared 510(k)s took a median 135 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 | 2 | 2 |
| PNN | Orthodontic Software | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
Most recent Software Nemotec S.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232698 | NemoScan | QIH | 2024-01-18 | 135 |
| K232549 | NemoCast | PNN | 2023-11-21 | 90 |
| K193003 | NemoCast | PNN | 2020-06-05 | 221 |
| K192475 | NemoFAB | LLZ | 2020-04-23 | 226 |
| K192571 | NemoScan | LLZ | 2019-12-11 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Software Nemotec S.L..
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 Software Nemotec S.L. have?
Software Nemotec S.L. has 5 FDA 510(k) clearances (first 2019, latest 2024), across 3 product codes in 2 review panels.
How long does FDA take to clear Software Nemotec S.L.'s 510(k)s?
The median time from FDA receipt to decision across Software Nemotec S.L.'s cleared 510(k)s is 135 days. Since 2017: 135 days, versus 131 days for all cleared 510(k)s in the same product codes.
What devices does Software Nemotec S.L. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 2); PNN (Orthodontic Software, 2); QIH (Automated Radiological Image Processing Software, 1).
Has Software Nemotec S.L. had device recalls?
openFDA lists no recalls under a recalling firm name matching Software Nemotec S.L. Related entities may recall under other names.
Next steps
- See all 5 Software Nemotec S.L. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Software Nemotec S.L.'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.