OPTELLUM LTD

Address:Optellum Ltd,Oxford Oxfordshire,GB

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer (POK) (2)

Premarket Exempt

Clear

Optellum Virtual Nodule Clinic - B816VNC2P10 Catalog Number : N/A

Device Description : Virtual Nodule Clinic (VNC) is a software application designed for trained medic 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.

Device Class : 2

Duns Number: 221210507

Premarket Exempt : No

Product Code : POK

Prescription Use : Yes

Device Count : 1

Optellum Virtual Nodule Clinic - B816VNC2P30 Catalog Number : N/A