510(k) Report

510(k) · Cleared

Cleared

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform

K202300510(k) TraditionalCleared Mar 5, 2021204-day reviewClass II21 CFR 892.2060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Descendants, by year cleared 2026: 1 descendant clearedDEN170022 · QuantX · Quantitative Insights, Inc. · 2017201620182020202220242026
Descendants, by generation 1 generation forward: 1 descendant DEN170022 · QuantX · Quantitative Insights, Inc. · 20170
  1. Root · 1 generation backDEN170022 QuantXQuantitative Insights, Inc. · 2017
  2. This deviceK202300 Optellum Virtual Nodule Clinic, Optellum software, Optellum platformOptellum, Ltd. · 2021
  3. 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

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN170022QuantXQuantitative Insights, Inc.2017—
0 (this device)K202300Optellum Virtual Nodule Clinic, Optellum software, Optellum platformOptellum, Ltd.2021—
+1K251769RevealAI-LungPrecision Medical Ventures, Inc. Dba Revealdx2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K202300, 2017–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242342 Fetal EchoScanscore 16.7 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*DEN170022QuantX
Summary 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…
Quantitative Insights, Inc.2017—

Also cleared against DEN170022: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K251769RevealAI-LungPrecision Medical Ventures, Inc. Dba Revealdx20260

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?

  • Its one ancestor has no recall.
  • Of its descendants, K251769 (Precision Medical Ventures, Inc. Dba Revealdx, 2026) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate DEN170022.

How does its category compare?

All POK devices

POK 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

2017: 12019: 12020: 22021: 22022: 12023: 12024: 62025: 52026 (partial year): 5
2007high 6 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · POK

119in 2025

2024: 161 days median2025: 119 days median2026 (partial year): 155 days median
2007high 161 (2024) · low 119 (2025)2026

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

2021: 1
2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code POK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20180—00
20191—00
20202—00
20212—01
20221—00
20231—00
2024616100
2025511900
202651550—

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.

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