De Novo · Granted
GrantedViz HCM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viz. Ai, Inc. · QXO Cardiovascular Machine Learning-Based Notification Software
Granted on Aug 3, 2023 as a new device type through De Novo after a 205-day review. 16 later devices descend from it.
- Decided
- Aug 3, 2023
- Review
- 205 days
- Class
- Class II
- Product code
- QXO
- Recalls
- None
16 later devices descend from it, 5 citing it directly.
- This deviceDEN230003 Viz HCMViz. Ai, Inc. · 2023
- Descendant · cites it directly · 8 of its ownK232699 Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. · 2023
- Descendant · 2 generations on · 4 of its ownK250652 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. · 2025
- Descendant · cites it directly · 3 of its ownK232686 CorVista® SystemCorvista Health, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK233666 CorVista System with PH Add-OnAnalytics For Life, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK252360 ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc. · 2026
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. · 2023 · cites it directly8descendants
- K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. · 2025 · 2 generations on4descendants
- K232686CorVista® SystemCorvista Health, Inc. · 2023 · cites it directly3descendants
- K233666CorVista System with PH Add-OnAnalytics For Life, Inc. · 2024 · 2 generations on2descendants
- K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc. · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| +1 | K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 2023 | — |
| +2 | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | 2025 | — |
| +1 | K232686 | CorVista® System | Corvista Health, Inc. | 2023 | — |
| +2 | K233666 | CorVista System with PH Add-On | Analytics For Life, Inc. | 2024 | — |
| +3 | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 0 |
Sources: FDA De Novo 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 QXO? 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 QXO device
- #1 K260332 EchoNextscore 11.5 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (16)
See all 165 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?
- Of its descendants, K232699 (Anumana, Inc., 2023) has gone furthest, with 8 descendants of its own.
How does its category compare?
All QXO devicesQXO Cardiovascular 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 · QXO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QXO
Too few QXO 510(k)s in any year since 2007 to give a median.
Recalls per year · QXO
No recall names QXO since 2007.
Adverse event reports per year · QXO
No MAUDE report names QXO 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 | 1 | — | 0 | — |
What is it indicated for?
Viz HCM is intended to be used in parallel to the standard of care to analyze recordings of 12-lead ECG made on compatible ECG devices. Viz HCM is capable of analyzing the ECG, detecting signs associated with hypertrophic cardiomyopathy (HCM), and allowing the user to view the ECG and analysis results. Viz HCM is indicated for use on 12-lead ECG recordings collected from patients 18 years of age or older. Viz HCM is not intended for use on patients with…
Read the full statement (143 words)
Viz HCM is intended to be used in parallel to the standard of care to analyze recordings of 12-lead ECG made on compatible ECG devices. Viz HCM is capable of analyzing the ECG, detecting signs associated with hypertrophic cardiomyopathy (HCM), and allowing the user to view the ECG and analysis results. Viz HCM is indicated for use on 12-lead ECG recordings collected from patients 18 years of age or older. Viz HCM is not intended for use on patients with implanted pacemakers.
Viz HCM is limited to analysis of ECG data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis. Viz HCM identifies patients for further HCM follow-up and does not replace the current standard of care methods for diagnosis of HCM. The results of the device are not intended to rule-out HCM follow-up.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230003 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230003: Viz HCM.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230003
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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