510(k) · Cleared
ClearedAIMI-Triage CXR PTX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radlogics, Inc. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Apr 8, 2020 as substantially equivalent to K190362 (Zebra Medical Vision, Ltd., 2019) after a 133-day review. Its family tree reaches back 3 generations to 2018. 2 later devices descend from it.
- Decided
- Apr 8, 2020
- Review
- 133 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 2 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 1 generation backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- This deviceK193300 AIMI-Triage CXR PTXRadlogics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK213566 ClearRead Xray PneumothoraxRiverain Technologies, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK211803 HealthPPTZebra Medical Vision, Ltd. · 2021
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 |
|---|---|---|---|---|---|
| −3 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −2 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −1 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| 0 (this device) | K193300 | AIMI-Triage CXR PTX | Radlogics, Inc. | 2020 | — |
| +1 | K213566 | ClearRead Xray Pneumothorax | Riverain Technologies, Inc. | 2022 | — |
| +1 | K211803 | HealthPPT | Zebra Medical Vision, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K190362 | HealthPNXSummary page 4…ion Name: Radiological computer-aided triage and notification software Regulatory Class: II Product Code: QFM Predicate Device: Zebra Medical Vision Ltd.’s HealthPNX (K190362) Device Description The AIMI-Triage CXR PTX provides a chest X-ray prioritization service for use by radiologists to identify fe… | 2019 |
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 2 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K213566 (Riverain Technologies, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K190362.
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. 2020, 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?
The AIMI-Triage CXR PTX Application is a notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to…
Read the full statement (189 words)
The AIMI-Triage CXR PTX Application is a notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes case-level output available to a PACS/workstation for worklist prioritization or triage. Identification of suspected cases of moderate to large sized pneumothorax is not for diagnostic use beyond notification.
The AIMI-Triage CXR PTX Application is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review, and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. Notified radiologists are responsible for engaging in appropriate patient evaluation as per local hospital procedure before making care-related decisions or requests. The device does not replace review and diagnosis of the X-rays by radiologists. The device is not intended to be used with plain film X-rays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193300: AIMI-Triage CXR PTX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193300
Report an extraction error
Are you the manufacturer?
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