510(k) · Cleared
ClearedViz AAA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viz. Ai, Inc. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Mar 17, 2023 as substantially equivalent to K213319 (Viz. Ai, Inc., 2022) after a 123-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Mar 17, 2023
- Review
- 123 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 5 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 4 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 3 generations backK192901 HealthVCFZebra Medical Vision, Ltd. · 2020
- 2 generations backK193271 uAI EasyTriage-RibShanghai United Imaging Intelligence Co., Ltd. · 2021
- 1 generation backK213319 Viz ANEURYSM, Viz ANXViz. Ai, Inc. · 2022
- This deviceK223443 Viz AAAViz. Ai, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −4 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −3 | K192901 | HealthVCF | Zebra Medical Vision, Ltd. | 2020 | — |
| −2 | K193271 | uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | 2021 | — |
| −1 | K213319 | Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | 2022 | — |
| 0 (this device) | K223443 | Viz AAA | Viz. Ai, Inc. | 2023 | — |
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 QFM? 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 QFM device
- #1 K211733 Lunit INSIGHT CXR Triagescore 21.2 · 4 generations · 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 |
|---|---|---|---|
| * | K213319 | Viz ANEURYSM, Viz ANXSummary page 4…redicate Device(s) Manufacturer Device Name Application No. Viz.ai, Inc. Viz ANEURYSM, Viz ANX K213319 1 Device Description Viz AAA is a radiological co… | 2022 |
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 5 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K213319.
How does its category compare?
All QFM devicesQFM Radiological Computer-Assisted Prioritization Software For Lesions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QFM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFM
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFM
No recall names QFM since 2007.
Adverse event reports per year · QFM
No MAUDE report names QFM 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 | 4 | 97 | 0 | 0 |
| 2020 | 4 | 172 | 0 | 0 |
| 2021 | 5 | 187 | 0 | 0 |
| 2022 | 9 | 121 | 0 | 0 |
| 2023 | 8 | 206 | 0 | 0 |
| 2024 | 6 | 192 | 0 | 0 |
| 2025 | 3 | 100 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks and vascular or endovascular specialists in workflow triage by flagging and prioritizing studies with suspected abdominal aortic aneurysms during routine patient care. Viz AAA uses an artificial intelligence algorithm to analyze images and highlight studies with suspected…
Read the full statement (243 words)
Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks and vascular or endovascular specialists in workflow triage by flagging and prioritizing studies with suspected abdominal aortic aneurysms during routine patient care.
Viz AAA uses an artificial intelligence algorithm to analyze images and highlight studies with suspected abdominal aortic aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
Analyzed images are available for review through the standalone application. When viewed through the standalone application the images are for informational purposes only and not for diagnostic use. The results of Viz AAA, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular or endovascular specialists who read the original medical images are responsible for the diagnostic decision. Viz AAA is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Viz AAA is limited to detecting aneurysms at least 3 cm in diameter. Viz AAA is intended to identify infra-renal, fusiform abdominal aortic aneurysms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223443: Viz AAA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223443
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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