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 Dec 29, 2020 as substantially equivalent to K190896 (Aidoc Medical, Ltd., 2019) and 5 other predicates after a 29-day review. Its family tree reaches back 4 generations to 2018. 17 later devices descend from it.
- Decided
- Dec 29, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to DEN170073 (2018). 7 ancestors in all. 17 later devices descend from it, 8 citing it directly.
- Root · 4 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 3 generations backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 2 generations backK190072 BriefCaseAidoc Medical, Ltd. · 2019
- 1 generation backK201020 BriefCaseAidoc Medical, Ltd. · 2020
- This deviceK203508 BriefCaseAidoc Medical, Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK220709 BriefCaseAidoc Medical, Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK213886 BriefCaseAidoc Medical, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK221330 BriefCaseAidoc Medical, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK222277 BriefCaseAidoc Medical, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK221314 BriefCaseAidoc Medical, Ltd. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K220709BriefCaseAidoc Medical, Ltd. · 2022 · cites it directly2descendants
- K213886BriefCaseAidoc Medical, Ltd. · 2022 · cites it directly2descendants
- K221330BriefCaseAidoc Medical, Ltd. · 2022 · cites it directly1descendant
- K222277BriefCaseAidoc Medical, Ltd. · 2022 · cites it directly1descendant
- K221314BriefCaseAidoc Medical, Ltd. · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −3 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| −2 | K190072 | BriefCase | Aidoc Medical, Ltd. | 2019 | — |
| −1 | K201020 | BriefCase | Aidoc Medical, Ltd. | 2020 | — |
| 0 (this device) | K203508 | BriefCase | Aidoc Medical, Ltd. | 2020 | — |
| +1 | K220709 | BriefCase | Aidoc Medical, Ltd. | 2022 | — |
| +1 | K213886 | BriefCase | Aidoc Medical, Ltd. | 2022 | — |
| +1 | K221330 | BriefCase | Aidoc Medical, Ltd. | 2022 | — |
| +1 | K222277 | BriefCase | Aidoc Medical, Ltd. | 2022 | — |
| +1 | K221314 | BriefCase | Aidoc Medical, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 7 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 K222884 Rapid NCCT Strokescore 17.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K190896 | BriefCaseSummary page 9…device Regulatory Class: Class II Product Code: QAS (21 C.F.R. 892.2080) Predicate Device: BriefCase (K190896) Device Description BriefCase is a radiological computer-assisted triage and notification software device. The software syste… | 2019 |
| * | K180647 | BriefCaseSummary page 13…on software Regulatory Class: Class II Product Code: QAS (21 C.F.R. 892.2080) Predicate Device: Aidoc Medical BriefCase (K180647) Reference Device: Qure.ai Technologies qER (K200921) Device Description BriefCase is a radiological computer-as… | 2018 |
| * | K190072 | BriefCaseSummary page 17…device Regulatory Class: Class II Product Code: QAS (21 C.F.R. 892.2080) Predicate Device: BriefCase (K190072) Device Description BriefCase is a radiological computer-assisted triage and notification software device. The software system… | 2019 |
| * | K193298 | BriefCaseSummary page 21…device Regulatory Class: Class II Product Code: QAS (21 C.F.R. 892.2080) Predicate Device: BriefCase (K193298) Device Description BriefCase is a radiological computer-assisted triage and notification software device. The software system… | 2020 |
| * | K201020 | BriefCaseSummary page 25…device Regulatory Class: Class II Product Code: QAS (21 C.F.R. 892.2080) Predicate Device: BriefCase (K201020) Device Description BriefCase is a radiological computer-assisted triage and notification software device. The software system… | 2020 |
| * | K192383 | BriefCaseSummary page 30…device Regulatory Class: Class II Product Code: QAS (21 C.F.R. 892.2080) Primary Predicate Device: BriefCase (K192383) Device Description BriefCase is a radiological computer-assisted triage and notification software device. The software system… | 2019 |
| † | K200921 | qER | 2020 |
What descends from it? (17)
See all 178 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 2 companies; a new generation was cleared every 8 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K220709 (Aidoc Medical, Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K190896.
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. 2020, 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 cervical spine CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of linear lucencies in the cervical spine bone in patterns compatible with fractures. BriefCase uses an artificial intelligence algorithm to…
Read the full statement (1,102 words)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of linear lucencies in the cervical spine bone in patterns compatible with fractures.
BriefCase uses an artificial intelligence algorithm to analyse images and highlight cases with detected findings 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 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 their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
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 appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Haemorrhage (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..
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT and CTPA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intracranial Hemorrhage (ICH) and Pulmonary Embolism (PE) pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings 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 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 their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intra-abdominal free gas (IFG) pathologies.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings 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 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 their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. .
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast enhanced chest CT images (but not dedicated CTPA protocol) CT. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive cases of Incidental Pulmonary Embolism (iPE) pathologies. For the iPE pathology, the software is only intended to be used on single-energy exams. The device in intended to work with GE and Siemens scanners only.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings 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 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 their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) pathologies.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings 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 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 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/K203508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203508: BriefCase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203508
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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