510(k) · Cleared
ClearedViz ANEURYSM, Viz ANX
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 Feb 18, 2022 as substantially equivalent to K193271 (Shanghai United Imaging Intelligence Co., Ltd., 2021) after a 137-day review. Its family tree reaches back 4 generations to 2018. 2 later devices descend from it.
- Decided
- Feb 18, 2022
- Review
- 137 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170073 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 3 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 2 generations backK192901 HealthVCFZebra Medical Vision, Ltd. · 2020
- 1 generation backK193271 uAI EasyTriage-RibShanghai United Imaging Intelligence Co., Ltd. · 2021
- This deviceK213319 Viz ANEURYSM, Viz ANXViz. Ai, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK230074 Rapid Aneurysm Triage and NotificationIschemaview, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK223443 Viz AAAViz. Ai, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −4 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −3 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −2 | K192901 | HealthVCF | Zebra Medical Vision, Ltd. | 2020 | — |
| −1 | K193271 | uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | 2021 | — |
| 0 (this device) | K213319 | Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | 2022 | — |
| +1 | K230074 | Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | 2023 | — |
| +1 | K223443 | Viz AAA | Viz. Ai, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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 |
|---|---|---|---|
| * | K193271 | uAI EasyTriage-RibSummary page 4…Device Name Application No. Shanghai United Imaging uAI EasyTriage-Rib K193271 Intelligence Co., Ltd. Device Description Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and… | 2021 |
What descends from it? (2)
2 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?
- The line of descent spans 4 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K230074 (Ischemaview, Inc., 2023) has gone furthest, with 0 descendants of its own.
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. 2022, 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 ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected aneurysms during routine patient care. Viz ANEURYSM uses an artificial intelligence algorithm to analyze images and highlight studies with suspected aneurysms in a…
Read the full statement (224 words)
Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected aneurysms during routine patient care.
Viz ANEURYSM uses an artificial intelligence algorithm to analyze images and highlight studies with suspected 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 ANEURYSM, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Radiologists who read the original medical images are responsible for the diagnostic decision. Viz ANEURYSM 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 ANEURYSM is limited to detecting aneurysms at least 4mm in diameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213319 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213319: Viz ANEURYSM, Viz ANX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213319
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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