510(k) · Cleared
ClearedBriefCase, RIB Fractures Triage (RibFx)
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 Apr 14, 2021 as substantially equivalent to K190072 (Aidoc Medical, Ltd., 2019) after a 196-day review. Its family tree reaches back 3 generations to 2018. 2 later devices descend from it.
- Decided
- Apr 14, 2021
- Review
- 196 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, 1 citing it directly.
- Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 2 generations backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 1 generation backK190072 BriefCaseAidoc Medical, Ltd. · 2019
- This deviceK202992 BriefCase, RIB Fractures Triage (RibFx)Aidoc Medical, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK230020 BriefCaseAidoc Medical, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK243548 BriefCase-TriageAidoc Medical, Ltd. · 2024
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 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| −1 | K190072 | BriefCase | Aidoc Medical, Ltd. | 2019 | — |
| 0 (this device) | K202992 | BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical, Ltd. | 2021 | — |
| +1 | K230020 | BriefCase | Aidoc Medical, Ltd. | 2023 | — |
| +2 | K243548 | BriefCase-Triage | Aidoc Medical, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K190072 | BriefCaseSummary page 4…device Regulatory Class: Class II Product Code: QFM (21 C.F.R. 892.2080) Predicate Device: BriefCase (K190072, for PE) Device Description BriefCase is a radiological computer-assisted triage and notification software device. The s… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230020 | BriefCase | 2023 | 1 |
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 2 companies; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K230020 (Aidoc Medical, Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K190072.
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?
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest CTs (with or without contrast). The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of three or more acute Rib fracture (RibFx) pathologies. BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect…
Read the full statement (173 words)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest CTs (with or without contrast). The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of three or more acute Rib fracture (RibFx) pathologies.
BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202992 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202992: BriefCase, RIB Fractures Triage (RibFx).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202992
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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