510(k) · Cleared
ClearedScaida BrainCT-ICH (v1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mlhealth 360 · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Nov 25, 2025 as substantially equivalent to K211179 (Infervision Medical Technology Co., Ltd., 2021) after a 263-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- Nov 25, 2025
- Review
- 263 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K211179 | InferRead CT Stroke.AISummary page 5…892.2080 Product Code(s) QAS Legally Marketed Predicate Devices: 21 CFR 807.92 (a) (3) Predicate # K211179 Predicate Trade Name (Primary InferRead CT Stroke.AI Predicate is listed first) Product Code… | 2021 |
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 7 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K211179.
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. 2025, 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?
Scaida BrainCT-ICH is a radiological computer aided notification software indicated for use in the analysis of non-contrast head CT images of adult patients (ages 22 and above). The device is intended to assist trained radiologists in workflow triage by flagging and communicating suspected positive findings of pathologies in head CT images, for Intracranial Hemorrhages (ICH). The suspected ICH could be part of any of these five subtypes: Intraparenchymal…
Read the full statement (216 words)
Scaida BrainCT-ICH is a radiological computer aided notification software indicated for use in the analysis of non-contrast head CT images of adult patients (ages 22 and above).
The device is intended to assist trained radiologists in workflow triage by flagging and communicating suspected positive findings of pathologies in head CT images, for Intracranial Hemorrhages (ICH). The suspected ICH could be part of any of these five subtypes: Intraparenchymal hemorrhage (IPH), Intraventricular hemorrhage (IVH), Subarachnoid hemorrhage (SAH), Subdural hemorrhage (SDH), and Epidural Hemorrhage (EDH). The Scaida BrainCT-ICH device does not provide this ICH subclassification to the user; it uses an artificial intelligence algorithm to analyze images, and it identifies cases with suspected ICH only.
The device does not alter the original medical image, does not remove cases from the queue, and is not intended to be used as a diagnostic device or for use in patients under 22 years of age. 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 Scaida BrainCT-ICH 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 radiologists 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/K250694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250694: Scaida BrainCT-ICH (v1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250694
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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