FDA UDI
In Commercial Distribution
🇺🇸 United States
Optellum Virtual Nodule Clinic
DI: B816VNC2P30
·
Model: 2.3
·
OPTELLUM LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Optellum Virtual Nodule Clinic
- Primary DI
- B816VNC2P30
- Version / Model
- 2.3
- Catalog Number
- N/A
- Company Name
- OPTELLUM LTD
- Labeler DUNS
- 221210507
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-15
- Public Version
- 1
- Public Version Date
- 2022-06-23
- Public Version Status
- New
- Public Device Record Key
- 3052c956-2122-41c9-8170-bd9a1cdd039f
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | Radiology | 892.2060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40867 | CT system application software | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B816VNC2P30 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202300 | 000 |