510(k) · Cleared
ClearedChest-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 Jul 20, 2021 as substantially equivalent to P000041 (Riverain Medical Group, 2001) after a 137-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it.
- Decided
- Jul 20, 2021
- Review
- 137 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P000041 (2001). 8 later devices descend from it, 5 citing it directly.
- Root · 1 generation backP000041 Rapidscreen RS-2000Riverain Medical Group · 2001
- This deviceK210666 Chest-CADImagen Technologies, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK213353 Aorta-CADImagen Technologies, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241620 ChestView USGleamer Sas · 2025
- Descendant · cites it directly · 1 of its ownK230085 Lung-CADImagen Technologies, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK252486 ChestView US (1.1)Gleamer · 2026
- Descendant · cites it directly · 0 of its ownK251934 qXR-DetectQure.Ai Technologies · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K213353Aorta-CADImagen Technologies, Inc. · 2022 · cites it directly2descendants
- K241620ChestView USGleamer Sas · 2025 · 2 generations on1descendant
- K230085Lung-CADImagen Technologies, Inc. · 2023 · cites it directly1descendant
- K252486ChestView US (1.1)Gleamer · 2026 · 3 generations on0descendants
- K251934qXR-DetectQure.Ai Technologies · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P000041 | Rapidscreen RS-2000 | Riverain Medical Group | 2001 | — |
| 0 (this device) | K210666 | Chest-CAD | Imagen Technologies, Inc. | 2021 | — |
| +1 | K213353 | Aorta-CAD | Imagen Technologies, Inc. | 2022 | — |
| +2 | K241620 | ChestView US | Gleamer Sas | 2025 | — |
| +1 | K230085 | Lung-CAD | Imagen Technologies, Inc. | 2023 | — |
| +3 | K252486 | ChestView US (1.1) | Gleamer | 2026 | — |
| +1 | K251934 | qXR-Detect | Qure.Ai Technologies | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 29.9 · 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 |
|---|---|---|---|
| * | P000041 | Rapidscreen RS-2000Summary page 5…published the final rule down-classifying medical image analyzers (product code MYN) from Class III to Class II. Therefore, Riverain Technologies’ RapidScreen™ RS-2000 (P000041) has been identified as the predicate device for Chest-CAD. 4. DEVICE DESCRIPTION Chest-CAD is a computer-assisted det… | 2001 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Chest-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using machine learning techniques to identify, categorize, and highlight suspicious regions of interest (ROI). Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. The device is intended for use as a concurrent reading aid for physicians. Chest-CAD 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/K210666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210666: Chest-CAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210666
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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