510(k) · Cleared
ClearedMedian LCS (internal name) / eyonis LCS (trade name) (1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Median Technologies · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Feb 6, 2026 as substantially equivalent to K241831 (Screenpoint Medical B.V., 2024) after a 269-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Feb 6, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN180005 (2018). No later device cites it as a predicate yet.
- Root · 6 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 5 generations backK181704 TransparaScreenpoint Medical B.V. · 2018
- 4 generations backK193229 TransparaScreenpoint Medical B.V. · 2020
- 3 generations backK210404 Transpara 1.7.0Screenpoint Medical B.V. · 2021
- 2 generations backK221347 Transpara 1.7.2Screenpoint Medical B.V. · 2022
- 1 generation backK241831 Transpara (2.1.0)Screenpoint Medical B.V. · 2024
- This deviceK251474 Median LCS (internal name) / eyonis LCS (trade name) (1.0)Median Technologies · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −5 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| −4 | K193229 | Transpara | Screenpoint Medical B.V. | 2020 | — |
| −3 | K210404 | Transpara 1.7.0 | Screenpoint Medical B.V. | 2021 | — |
| −2 | K221347 | Transpara 1.7.2 | Screenpoint Medical B.V. | 2022 | — |
| −1 | K241831 | Transpara (2.1.0) | Screenpoint Medical B.V. | 2024 | — |
| 0 (this device) | K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | 2026 | — |
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 QDQ? 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 QDQ device
- #1 K241831 Transpara (2.1.0)score 15.6 · 5 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 |
|---|---|---|---|
| * | K241831 | Transpara (2.1.0)Summary page 5…Predicate Device Trade Name TransparaTM 2.1.0 Legal Manufacturer ScreenPoint Medical B.V. 510(k) Number K241831 Device Radiological Computer Assisted Detection/Diagnosis Software for… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K241831.
How does its category compare?
All QDQ devicesQDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QDQ
10so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QDQ
216in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QDQ
No recall names QDQ since 2007.
Adverse event reports per year · QDQ
No MAUDE report names QDQ since 2007.
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 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 173 | 0 | 0 |
| 2021 | 5 | 169 | 0 | 0 |
| 2022 | 4 | 131 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 7 | 153 | 0 | 0 |
| 2025 | 5 | 216 | 0 | 0 |
| 2026 | 10 | 154 | 0 | — |
What is it indicated for?
eyonis® LCS is indicated for use by radiologists. eyonis® LCS assists radiologists in the detection, localization and characterization of solid and part-solid probably benign, suspicious and very suspicious pulmonary parenchymal nodules with a diameter of 4-30 mm (pure ground glass, mediastinal lesions and masses - including but not limited to hilar masses - are excluded). The eyonis® LCS - lung nodules result report provides, for each reported nodule…
Read the full statement (185 words)
eyonis® LCS is indicated for use by radiologists. eyonis® LCS assists radiologists in the detection, localization and characterization of solid and part-solid probably benign, suspicious and very suspicious pulmonary parenchymal nodules with a diameter of 4-30 mm (pure ground glass, mediastinal lesions and masses - including but not limited to hilar masses - are excluded).
The eyonis® LCS - lung nodules result report provides, for each reported nodule, the following information: slice number, malignancy score, full snapshot, close-up snapshot, diameters (long/short/average) and volume.
The eyonis® LCS - lung nodules result report is indicated to aid in diagnosis as well as to aid in follow-up exam evaluations and as an adjunct to support clinical/patient management.
It cannot, however, substitute for medical experts’ clinical judgment.
The target population is high-risk patients eligible for participation in lung cancer screening programs (as per USPSTF criteria) with the exception of patients with pure ground glass cancer only and hilar/mediastinal cancer who are excluded from the intended population.
It is indicated for use with low-dose Chest CT DICOM images. The exact specifications are described in a DICOM Conformance Statement (DCS) document.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251474: Median LCS (internal name) / eyonis LCS (trade name) (1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251474
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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