Optellum Virtual Nodule Clinic, Optellum Software, Optellum Platform
Optellum Ltd
OPTELLUM LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015478020 | 3015478020 | OPTELLUM LTD | 1 | N | 2026-01-01 | Five Kings Meadow Osney Mead Oxford Oxfordshire GB OX2 0DP |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 229731 | 1977273071 | K202300 | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | POK | 2021-03-05 |
| 229731 | 2062279348 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| POK | 1 | 2021-03-05 |
PMN#
GUDID#
Optellum Virtual Nodule Clinic - Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
2022-06-15
Optellum Virtual Nodule Clinic - Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
2021-04-08