510(k) · Cleared
ClearedCorVista® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corvista Health, Inc. · QXX Coronary Artery Disease Machine Learning-Based Notification Software
Cleared on Sep 8, 2023 as substantially equivalent to DEN230003 (Viz. Ai, Inc., 2023) after a 7-day review. Its family tree reaches back 1 generation to 2023. 3 later devices descend from it.
- Decided
- Sep 8, 2023
- Review
- 7 days
- Class
- Class II
- Product code
- QXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230003 (2023). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- This deviceK232686 CorVista® SystemCorvista Health, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK233666 CorVista System with PH Add-OnAnalytics For Life, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253699 Tempus ECG-PHTempus AI, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253576 CorVista System® with PCWP Add-OnAnalytics For Life, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| 0 (this device) | K232686 | CorVista® System | Corvista Health, Inc. | 2023 | — |
| +1 | K233666 | CorVista System with PH Add-On | Analytics For Life, Inc. | 2024 | — |
| +2 | K253699 | Tempus ECG-PH | Tempus AI, Inc. | 2026 | — |
| +2 | K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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 QXX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN230003 | Viz HCMSummary page 5…Predicate Trade / Device Name Viz HCM 510(k) Submitter / Holder Viz.ai, Inc. 510(k) Number DEN230003 Regulation Number 21 CFR 870.2380 Classification Panel Cardiovascular Product Code… | 2023 |
| † | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | 2020 |
| † | K210392 | WorkMate Claris System | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233666 | CorVista System with PH Add-On | 2024 | 2 |
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 QXX devicesQXX Coronary Artery Disease Machine Learning-Based Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QXX
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QXX
Too few QXX 510(k)s in any year since 2007 to give a median.
Recalls per year · QXX
No recall names QXX since 2007.
Adverse event reports per year · QXX
No MAUDE report names QXX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient’s signs, symptoms, and clinical history as an aid in diagnosis.
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/K232686 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232686: CorVista® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232686
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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