510(k) · Cleared
ClearedLung AI (LAI001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exo, Inc. · MYN Analyzer, Medical Image
Cleared on Apr 24, 2025 as substantially equivalent to K230085 (Imagen Technologies, Inc., 2023) after a 196-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Apr 24, 2025
- Review
- 196 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P000041 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K230085 | Lung-CADSummary page 5…oduct Code MYN Regulatory Class II Predicate Device Proprietary Name Lung-CAD Premarket Notification K230085 Classification Name Medical Image Analyzer Regulation Number 21 CFR 892.2070 Product Code… | 2023 |
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 24 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 AI software device is a Computer-Aided Detection (CADe) tool designed to assist in the detection of consolidation/atelectasis and pleural effusion during the review of lung ultrasound scans. The software is an adjunctive tool to alert users to the presence of regions of interest (ROI) with consolidation/atelectasis and pleural effusion within the analyzed lung ultrasound cine clip. Lung AI is intended to be used on images collected from the PLAPS…
Read the full statement (187 words)
Lung AI software device is a Computer-Aided Detection (CADe) tool designed to assist in the detection of consolidation/atelectasis and pleural effusion during the review of lung ultrasound scans.
The software is an adjunctive tool to alert users to the presence of regions of interest (ROI) with consolidation/atelectasis and pleural effusion within the analyzed lung ultrasound cine clip.
Lung AI is intended to be used on images collected from the PLAPS point, in accordance with the BLUE protocol.
The intended users are healthcare professionals who are trained and qualified in performing lung ultrasound and routinely perform lung ultrasounds as part of their current practice in a point-of-care environment—namely Emergency Departments (EDs). The device was not designed and tested with use environments representing EMTs and military medics.
Lung AI is not intended for clinical diagnosis and does not replace the healthcare provider’s judgment or other diagnostic tests in the standard care for lung ultrasound findings. All cases where a Chest CT scan and/or Chest X-ray is part of the standard of care should undergo these imaging procedures, irrespective of the device output.
The software is indicated for adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243239: Lung AI (LAI001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243239
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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