Data / Medical devices / Netherlands / Augmedit
Augmedit: FDA-registered device maker in Naarden Noord-Holland, Netherlands, 1 510(k) clearance
Augmedit is registered with the FDA (registration 3036725840) in Naarden Noord-Holland, Netherlands. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 10, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036725840
- Address
- Galerij 15, Naarden Noord-Holland, Netherlands, 1411 LH
- Owner or operator
- Augmedit (10092651)
- Roles
- Manufacturer
- First device listed
- February 3, 2025
- Registered through
- 2026
- Brand names listed
- Lumi, LumiNE US
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 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 |
|---|---|---|---|---|---|---|
| September 10, 2024 | K240094 | LumiNE US; Lumi | QIH | Substantially Equivalent | Augmedit B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated September 10, 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.