510(k) · Cleared
ClearedInferRead CT Stroke.AI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infervision Medical Technology Co., Ltd. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Aug 12, 2021 as substantially equivalent to K180647 (Aidoc Medical, Ltd., 2018) after a 114-day review. Its family tree reaches back 2 generations to 2018. 5 later devices descend from it.
- Decided
- Aug 12, 2021
- Review
- 114 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170073 (2018). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 1 generation backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- This deviceK211179 InferRead CT Stroke.AIInfervision Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK223240 Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK252366 a2z-Unified-TriageA2z Radiology Ai, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK260906 a2z-Abdo-TriageA2z Radiology Ai, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250694 Scaida BrainCT-ICH (v1.0)Mlhealth 360 · 2025
- Descendant · 2 generations on · 0 of its ownK231767 Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K223240Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd. · 2023 · cites it directly3descendants
- K252366a2z-Unified-TriageA2z Radiology Ai, Inc. · 2025 · 2 generations on1descendant
- K260906a2z-Abdo-TriageA2z Radiology Ai, Inc. · 2026 · 3 generations on0descendants
- K250694Scaida BrainCT-ICH (v1.0)Mlhealth 360 · 2025 · cites it directly0descendants
- K231767Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −1 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| 0 (this device) | K211179 | InferRead CT Stroke.AI | Infervision Medical Technology Co., Ltd. | 2021 | — |
| +1 | K223240 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty, Ltd. | 2023 | — |
| +2 | K252366 | a2z-Unified-Triage | A2z Radiology Ai, Inc. | 2025 | — |
| +3 | K260906 | a2z-Abdo-Triage | A2z Radiology Ai, Inc. | 2026 | — |
| +1 | K250694 | Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | 2025 | — |
| +2 | K231767 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K180647 | BriefCaseSummary page 7…tion for all cases. Detailed Comparison of the Subject and Predicate Devices Item InferRead CT Stroke.AI Aidoc Briefcase ICH (K180647) Comparison (Subject Device) (Predicate Device) Intended Use… | 2018 |
What descends from it? (5)
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 3 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223240 (Annalise-Ai Pty, Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 11 other devices also cite its predicate K180647.
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. 2021, 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?
InferRead CT Stroke.Al is a radiological computer aided triage and notification software 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 suspected positive findings of intracranial hemorrhage (ICH). InferRead CT Stroke.Al uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a standalone desktop…
Read the full statement (184 words)
InferRead CT Stroke.Al is a radiological computer aided triage and notification software 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 suspected positive findings of intracranial hemorrhage (ICH).
InferRead CT Stroke.Al 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 a worklist with marked cases of suspected ICH findings. The device does not alter the original medical image, does not remove cases from queue, and is not intended to be used as a diagnostic device. If the clinician does not view the case, or if a case is not flagged, cases remain to be processed per the standard of care.
The results of InferRead CT Stroke.Al 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211179: InferRead CT Stroke.AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211179
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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