Optellum Virtual Nodule Clinic N/A

GUDID B816VNC2P10

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.

OPTELLUM LTD

CT system application software

• Primary Device ID: B816VNC2P10
• NIH Device Record Key: 327be13c-b3d3-4259-a36f-63a1f7861629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optellum Virtual Nodule Clinic
• Version Model Number: 2.1.0
• Catalog Number: N/A
• Company DUNS: 221210507
• Company Name: OPTELLUM LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B816VNC2P10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202300

FDA Product Code

• POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-16
• Device Publish Date: 2021-04-08

On-Brand Devices [Optellum Virtual Nodule Clinic]

• B816VNC2P10: Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals
• B816VNC2P30: Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals