510(k) · Cleared
ClearedLung-CAD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imagen Technologies, Inc. · MYN Analyzer, Medical Image
Cleared on Oct 3, 2023 as substantially equivalent to K210666 (Imagen Technologies, Inc., 2021) after a 265-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Oct 3, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P000041 (2001). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K243239Lung AI (LAI001)Exo, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P000041 | Rapidscreen RS-2000 | Riverain Medical Group | 2001 | — |
| −1 | K210666 | Chest-CAD | Imagen Technologies, Inc. | 2021 | — |
| 0 (this device) | K230085 | Lung-CAD | Imagen Technologies, Inc. | 2023 | — |
| +1 | K243239 | Lung AI (LAI001) | Exo, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 MYN? 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 MYN device
- #1 K210365 Second Opinionscore 30.0 · 1 generation · 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 |
|---|---|---|---|
| * | K210666 | Chest-CADSummary page 6…Page 3 of 8 6. SUBSTANTIAL EQUIVALENCE Comparison of Indications The predicate device for Lung-CAD is Chest-CAD (K210666). Chest-CAD has the following FDA-cleared Indications for Use: Chest-CAD is a computer-assisted detection (CADe) software de… | 2021 |
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 |
|---|---|---|---|
| K243239 | Lung AI (LAI001) | 2025 | 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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 20.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243239 (Exo, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K210666.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MYN
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYN
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYN
No recall names MYN since 2007.
Adverse event reports per year · MYN
2in 2025
MAUDE reports naming product code MYN, 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 | 5 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 6 | — | 0 | 0 |
| 2013 | 4 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 5 | 273 | 0 | 0 |
| 2023 | 10 | 229 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 14 | 210 | 0 | 2 |
| 2026 | 7 | 128 | 0 | — |
What is it indicated for?
Lung-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for lung hyperinflation. The device uses a deep learning algorithm to identify regions of interest (ROIs) with lung hyperinflation and produces boxes around the ROIs.
Lung-CAD is intended for use as a concurrent reading aid for physicians interpreting chest X-rays. The device is not intended for clinical diagnosis of any disease. It does not replace the role of the physician or of other diagnostic testing in the standard of care for lung parenchymal findings. Lung-CAD is indicated for adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230085 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230085: Lung-CAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230085
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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