510(k) · Cleared
ClearedOptellum Virtual Nodule Clinic, Optellum software, Optellum platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optellum, Ltd. · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Cleared on Mar 5, 2021 as substantially equivalent to DEN170022 (Quantitative Insights, Inc., 2017) after a 204-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.
- Decided
- Mar 5, 2021
- Review
- 204 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170022 (2017). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN170022 QuantXQuantitative Insights, Inc. · 2017
- This deviceK202300 Optellum Virtual Nodule Clinic, Optellum software, Optellum platformOptellum, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK251769 RevealAI-LungPrecision Medical Ventures, Inc. Dba Revealdx · 2026
Most influential descendants
Showing 1 of 1 · See all- K251769RevealAI-LungPrecision Medical Ventures, Inc. Dba Revealdx · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170022 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| 0 (this device) | K202300 | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | Optellum, Ltd. | 2021 | — |
| +1 | K251769 | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in POK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new POK device
- #1 K242342 Fetal EchoScanscore 16.7 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170022 | QuantXSummary page 4…laims equivalence. Predicate device name: QuantX Predicate device manufacturer: Quantitative Insights, Inc Predicate device PMA Number: DEN170022 Device classification name: Computer-Assisted Diagnostic Software For Lesions S… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251769 | RevealAI-Lung | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All POK devicesPOK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · POK
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POK
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POK
No recall names POK since 2007.
Adverse event reports per year · POK
1in 2021
MAUDE reports naming product code POK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 6 | 161 | 0 | 0 |
| 2025 | 5 | 119 | 0 | 0 |
| 2026 | 5 | 155 | 0 | — |
What is it indicated for?
Virtual Nodule Clinic (VNC) is a software device used in the tracking, assessment and characterization of incidentally detected pulmonary nodules. VNC includes a computer-aided diagnosis (CADx) function, available only to pulmonologists and radiologists. This automatically analyzes user-selected regions of interest (ROI) within lung CT data to provide volumetric and computer analysis based on morphological characteristics. Using only imaging features…
Read the full statement (321 words)
Virtual Nodule Clinic (VNC) is a software device used in the tracking, assessment and characterization of incidentally detected pulmonary nodules.
VNC includes a computer-aided diagnosis (CADx) function, available only to pulmonologists and radiologists. This automatically analyzes user-selected regions of interest (ROI) within lung CT data to provide volumetric and computer analysis based on morphological characteristics. Using only imaging features extracted from the CT image data, an artificial intelligence algorithm calculates a single value, the LCP-CNN score, which is displayed to the user. The LCP-CNN score is analyzed relative to LCP-CNN scores generated on a database of cases with known ground-truth using a histogram display format. The LCP-CNN score may be useful in the characterization of pulmonary nodules during image interpretation and may be used as one input to clinical decision making when following published clinical guidelines.
VNC’s LCP-CNN score is indicated for the evaluation of incidentally detected solid and semi-solid pulmonary nodules of diameter 5-30mm in patients aged 35 years or above. In cases where multiple abnormalities are present, VNC’s LCP-CNN score can be used to assess each abnormality independently.
Note that LCP-CNN is not indicated for lung cancer screening nor is it indicated for nodules of pure ground glass opacity. In addition, high contrast CT images were not used in clinical validation (as measured as >300HU median attenuation in the aortic arch) and the validation data also excluded CT images with only calcified nodules (since these are typically considered to be benign), with implants, motion artifacts, missing slices, or cases with greater than 5 nodules. Finally, the validation data excluded patients with history of cancer of less than 5 years to avoid the presence of metastatic lesions.
Users other than radiologists and pulmonologists, e.g. clinicians, nurses, nurse practitioners and navigators, may use VNC to view CT images and reports, organize patient management workflow, track patients, record management decisions and organize nodule clinics. For these users, the LCP-CNN score is unavailable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202300: Optellum Virtual Nodule Clinic, Optellum software, Optellum platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202300
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026