510(k) · Cleared
ClearedBriefCase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aidoc Medical, Ltd. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Aug 1, 2018 as substantially equivalent to DEN170073 (Viz.Al, Inc., 2018) after a 142-day review. Its family tree reaches back 1 generation to 2018. 73 later devices descend from it.
- Decided
- Aug 1, 2018
- Review
- 142 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170073 (2018). 73 later devices descend from it, 12 citing it directly.
- Root · 1 generation backDEN170073 ContaCTViz.Al, Inc. · 2018
- This deviceK180647 BriefCaseAidoc Medical, Ltd. · 2018
- Descendant · cites it directly · 30 of its ownK190072 BriefCaseAidoc Medical, Ltd. · 2019
- Descendant · cites it directly · 20 of its ownK193298 BriefCaseAidoc Medical, Ltd. · 2020
- Descendant · cites it directly · 19 of its ownK190896 BriefCaseAidoc Medical, Ltd. · 2019
- Descendant · 2 generations on · 18 of its ownK201020 BriefCaseAidoc Medical, Ltd. · 2020
- Descendant · cites it directly · 18 of its ownK192383 BriefCaseAidoc Medical, Ltd. · 2019
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K190072BriefCaseAidoc Medical, Ltd. · 2019 · cites it directly30descendants
- K193298BriefCaseAidoc Medical, Ltd. · 2020 · cites it directly20descendants
- K190896BriefCaseAidoc Medical, Ltd. · 2019 · cites it directly19descendants
- K201020BriefCaseAidoc Medical, Ltd. · 2020 · 2 generations on18descendants
- K192383BriefCaseAidoc Medical, Ltd. · 2019 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| 0 (this device) | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| +1 | K190072 | BriefCase | Aidoc Medical, Ltd. | 2019 | — |
| +1 | K193298 | BriefCase | Aidoc Medical, Ltd. | 2020 | — |
| +1 | K190896 | BriefCase | Aidoc Medical, Ltd. | 2019 | — |
| +2 | K201020 | BriefCase | Aidoc Medical, Ltd. | 2020 | — |
| +1 | K192383 | BriefCase | Aidoc Medical, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 4 | 0 |
| 2022 | 13 | 0 |
| 2023 | 10 | 0 |
| 2024 | 11 | 0 |
| 2025 | 12 | 0 |
| 2026 | 10 | 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 QAS? 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 QAS device
- #1 K203508 BriefCasescore 25.5 · 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 |
|---|---|---|---|
| * | DEN170073 | ContaCTSummary page 4…ory Class: Class II Product Code: QAS (21 C.F.R. 892.2080) Predicate Device: Viz.AI’s ContaCT (DEN170073) Device Description BriefCase is a radiological computer-assisted triage and notification software device. The software system… | 2018 |
What descends from it? (73)
See all 7312 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?
How does its category compare?
All QAS devicesQAS Radiological Computer-Assisted Triage And Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QAS
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAS
101in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAS
No recall names QAS since 2007.
Adverse event reports per year · QAS
No MAUDE report names QAS 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 | 3 | — | 0 | 0 |
| 2019 | 5 | 111 | 0 | 0 |
| 2020 | 12 | 112 | 0 | 0 |
| 2021 | 5 | 86 | 0 | 0 |
| 2022 | 15 | 116 | 0 | 0 |
| 2023 | 11 | 98 | 0 | 0 |
| 2024 | 12 | 136 | 0 | 0 |
| 2025 | 15 | 101 | 0 | 0 |
| 2026 | 11 | 104 | 0 | — |
What is it indicated for?
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH) . BriefCase uses an artificial intelligence algorithm to analyze images and highlight…
Read the full statement (176 words)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH) .
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH 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 are intended to be used in conjunction with other patient information and based on 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/K180647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180647: BriefCase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180647
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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