Data / Medical devices / Spain / Software Nemotec, S.L.
Software Nemotec, S.L.: FDA-registered device maker in Leganes Madrid(Province), Spain, 5 510(k) clearances
Software Nemotec, S.L. is registered with the FDA (registration 3016446349) in Leganes Madrid(Province), Spain. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 18, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016446349
- Address
- Av. Juan Caramuel, 1, Leganes Madrid(Province), Spain, 28919
- Owner or operator
- Software Nemotec, S.L. (10062432)
- Roles
- Manufacturer
- First device listed
- January 25, 2020
- Registered through
- 2027
- Brand names listed
- NemoCast, NemoFAB, NemoScan
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Orthodontic Software | PNN | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 18, 2024 | K232698 | NemoScan | QIH | Substantially Equivalent | Software Nemotec S.L. | accessdata.fda.gov |
| November 21, 2023 | K232549 | NemoCast | PNN | Substantially Equivalent | Software Nemotec S.L. | accessdata.fda.gov |
| June 5, 2020 | K193003 | NemoCast | PNN | Substantially Equivalent | Software Nemotec S.L. | accessdata.fda.gov |
| April 23, 2020 | K192475 | NemoFAB | LLZ | Substantially Equivalent | Software Nemotec S.L. | accessdata.fda.gov |
| December 11, 2019 | K192571 | NemoScan | LLZ | Substantially Equivalent | Software Nemotec S.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
- All makers of Orthodontic Software
Updated January 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.