510(k) · Cleared
CleareduAI EasyTriage-Rib
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Intelligence Co., Ltd. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Jan 15, 2021 as substantially equivalent to K192901 (Zebra Medical Vision, Ltd., 2020) after a 416-day review. Its family tree reaches back 3 generations to 2018. 3 later devices descend from it.
- Decided
- Jan 15, 2021
- Review
- 416 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 2 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 1 generation backK192901 HealthVCFZebra Medical Vision, Ltd. · 2020
- This deviceK193271 uAI EasyTriage-RibShanghai United Imaging Intelligence Co., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK213319 Viz ANEURYSM, Viz ANXViz. Ai, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK230074 Rapid Aneurysm Triage and NotificationIschemaview, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK223443 Viz AAAViz. Ai, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −3 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −2 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −1 | K192901 | HealthVCF | Zebra Medical Vision, Ltd. | 2020 | — |
| 0 (this device) | K193271 | uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | 2021 | — |
| +1 | K213319 | Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | 2022 | — |
| +2 | K230074 | Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | 2023 | — |
| +2 | K223443 | Viz AAA | Viz. Ai, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K192901 | HealthVCF Cleared while this submission was under review Summary page 5…ssisted Prioritization Software For Lesions Regulatory Class: Class II Product Code: QFM (21 C.F.R. 892.2080) Predicate Device: Zebra Medical Vision Ltd.’s HealthVCF (K192901) Device Description uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device indicated fo… | 2020 |
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 |
|---|---|---|---|
| K213319 | Viz ANEURYSM, Viz ANX | 2022 | 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?
- The line of descent spans 3 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K213319 (Viz. Ai, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K192901.
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. 2021, 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?
uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing trauma studies with suspected positive findings of multiple (3 or more) acute rib fracture(s). uAI EasyTriage-Rib uses an artificial intelligence algorithm to analyze images and highlight studies with…
Read the full statement (178 words)
uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing trauma studies with suspected positive findings of multiple (3 or more) acute rib fracture(s).
uAI EasyTriage-Rib uses an artificial intelligence algorithm to analyze images and highlight studies with suspected multiple (3 or more) acute rib fracture(s) in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The user is presented with notifications of cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of uAI EasyTriage-Rib, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Notified radiologists who read the original medical images are responsible for the diagnostic decision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193271: uAI EasyTriage-Rib.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193271
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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