510(k) · Cleared
ClearedAorta-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 Sep 20, 2022 as substantially equivalent to K210666 (Imagen Technologies, Inc., 2021) after a 347-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Sep 20, 2022
- Review
- 347 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P000041 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP000041 Rapidscreen RS-2000Riverain Medical Group · 2001
- 1 generation backK210666 Chest-CADImagen Technologies, Inc. · 2021
- This deviceK213353 Aorta-CADImagen Technologies, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK241620 ChestView USGleamer Sas · 2025
- Descendant · 2 generations on · 0 of its ownK252486 ChestView US (1.1)Gleamer · 2026
Most influential descendants
Showing 2 of 2 · See allView 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) | K213353 | Aorta-CAD | Imagen Technologies, Inc. | 2022 | — |
| +1 | K241620 | ChestView US | Gleamer Sas | 2025 | — |
| +2 | K252486 | ChestView US (1.1) | Gleamer | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K210666 | Chest-CADSummary page 6…Page 3 of 10 6. SUBSTANTIAL EQUIVALENCE Comparison of Indications The predicate device for Aorta-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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241620 | ChestView US | 2025 | 1 |
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 21 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, K241620 (Gleamer Sas, 2025) has gone furthest, with 1 descendant 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. 2022, 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?
Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious
regions of interest (ROIs). The device uses a deep learning algorithm to identify ROIs and produces boxes around the
ROIs. The boxes are labeled with one of the following radiographic findings: Aortic calcification or Dilated aorta.
Aorta-CAD is intended for use as a concurrent reading aid for physicians looking for ROIs with radiographic findings
suggestive of Aortic Atherosclerosis or Aortic Ectasia. It does not replace the role of the physician or of other diagnostic
testing in the standard of care. Aorta-CAD is indicated for adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213353: Aorta-CAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213353
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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