510(k) · Cleared
ClearedBriefCase-Triage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aidoc Medical, Ltd. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Dec 11, 2024 as substantially equivalent to K230020 (Aidoc Medical, Ltd., 2023) after a 26-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Dec 11, 2024
- Review
- 26 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 backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 3 generations backK190072 BriefCaseAidoc Medical, Ltd. · 2019
- 2 generations backK202992 BriefCase, RIB Fractures Triage (RibFx)Aidoc Medical, Ltd. · 2021
- 1 generation backK230020 BriefCaseAidoc Medical, Ltd. · 2023
- This deviceK243548 BriefCase-TriageAidoc Medical, Ltd. · 2024
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 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| −3 | K190072 | BriefCase | Aidoc Medical, Ltd. | 2019 | — |
| −2 | K202992 | BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical, Ltd. | 2021 | — |
| −1 | K230020 | BriefCase | Aidoc Medical, Ltd. | 2023 | — |
| 0 (this device) | K243548 | BriefCase-Triage | Aidoc Medical, Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K230020 | BriefCaseSummary page 4…device Regulatory Class: Class II Product Code: QFM Primary Predicate Device: BriefCase-Triage for RibFx (K230020) Reference Device: BriefCase-Triage for CSF (K242837) Device Description BriefCase-Triage is a radiological compu… | 2023 |
| † | K242837 | BriefCase-Triage | 2024 |
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 6 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
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. 2024, 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?
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT images with or without contrast that include the ribs, in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies.…
Read the full statement (185 words)
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT images with or without contrast that include the ribs, in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies.
BriefCase-Triage uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected RibFx 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 BriefCase-Triage are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243548 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243548: BriefCase-Triage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243548
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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