Data / Medical devices / United Kingdom / Optellum Ltd
Optellum Ltd: FDA-registered device maker in Oxford Oxfordshire, United Kingdom, 1 510(k) clearance
Optellum Ltd is registered with the FDA (registration 3015478020) in Oxford Oxfordshire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 5, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015478020
- Address
- Five Kings Meadow Osney Mead, Oxford Oxfordshire, United Kingdom, OX2 0DP
- Owner or operator
- Optellum Ltd (10060418)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 31, 2021
- Registered through
- 2026
- Brand names listed
- Optellum Virtual Nodule Clinic, Optellum platform, Optellum software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 5, 2021 | K202300 | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | POK | Substantially Equivalent | Optellum, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 5, 2021. 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.