Optellum Virtual Nodule Clinic

Primary DI
B816VNC2P30
Brand
Optellum Virtual Nodule Clinic
Company
OPTELLUM LTD
Model
2.3
Catalog number
N/A
Device description
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.
Published
2022-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For CancerRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202300000Optellum Virtual Nodule Clinic, Optellum software, Optellum platformOptellum, Ltd.2021-03-05POK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B816VNC2P30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
CT system application softwareAn application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
221210507
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B816VNC2P10Optellum Virtual Nodule Clinic2.1.0N/A2021-04-08

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