510(k) · Cleared
ClearedChestView US (1.1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gleamer · MYN Analyzer, Medical Image
Cleared on Sep 9, 2026 as substantially equivalent to K241620 (Gleamer Sas, 2025) after a 398-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Sep 9, 2026
- Review
- 398 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to P000041 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backP000041 Rapidscreen RS-2000Riverain Medical Group · 2001
- 3 generations backK210666 Chest-CADImagen Technologies, Inc. · 2021
- 2 generations backK213353 Aorta-CADImagen Technologies, Inc. · 2022
- 1 generation backK241620 ChestView USGleamer Sas · 2025
- This deviceK252486 ChestView US (1.1)Gleamer · 2026
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 |
|---|---|---|---|
| * | K241620 | ChestView USSummary page 5…21 CFR 892.2070 Product Code MYN Classification Class II 3. Predicate Device Predicate Device ChestView US 510(k) Number K241620 4. Device Description ChestView US is a radiological Computer-Assisted Detection (CADe) software device intended to analyze… | 2025 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 4 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. 2026, 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?
ChestView US is a radiological Computer-Assisted Detection (CADe) software device that analyzes frontal and lateral chest radiographs of patients presenting with symptoms (e.g. dyspnea, cough, pain) or suspected for findings related to regions of interest (ROIs) in the lungs, airways, mediastinum/hila and pleural space. The device uses machine learning techniques to identify and produces boxes around the ROIs. The boxes are labeled with one of the…
Read the full statement (129 words)
ChestView US is a radiological Computer-Assisted Detection (CADe) software device that analyzes frontal and lateral chest radiographs of patients presenting with symptoms (e.g. dyspnea, cough, pain) or suspected for findings related to regions of interest (ROIs) in the lungs, airways, mediastinum/hila and pleural space. The device uses machine learning techniques to identify and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings: Nodule, Pleural space abnormality, Mediastinum/Hila abnormality, and Consolidation.
ChestView US is intended for use as a concurrent reading aid for radiologists and emergency medicine physicians. It does not replace the role of radiologists and emergency medicine physicians or of other diagnostic testing in the standard of care. ChestView US is for prescription use only and is indicated for adults only.
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/K252486 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252486: ChestView US (1.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252486
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026