510(k) · Cleared
ClearedHyper Insight - ICH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sk, Inc. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Jul 1, 2024 as substantially equivalent to K193658 (Viz. Ai, Inc., 2020) after a 147-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- Jul 1, 2024
- Review
- 147 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 |
|---|---|---|---|
| * | K193658 | Viz ICHSummary page 5…ware • Performance Data 510k Number Trade or Proprietary or Model Name Manufacturer Product Code Predicate Type K193658 Viz ICH Viz.ai, Inc. QAS Primary Predica… | 2020 |
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 6 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K193658.
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. 2024, 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?
Hyper Insight - ICH is a notification-only workflow tool for trained clinicians to identify patients' brain CT images and share them with medical specialists in parallel with standard patient care workflow. Hyper Insight - ICH uses deep learning-based AI algorithms to analyze images to find suspected intracranial hemorrhage and notifies and shares the findings to medical specialists. Identification of images with suspected intracranial hemorrhage is for…
Read the full statement (186 words)
Hyper Insight - ICH is a notification-only workflow tool for trained clinicians to identify patients' brain CT images and share them with medical specialists in parallel with standard patient care workflow. Hyper Insight - ICH uses deep learning-based AI algorithms to analyze images to find suspected intracranial hemorrhage and notifies and shares the findings to medical specialists. Identification of images with suspected intracranial hemorrhage is for notification purposes only, not diagnostic purposes.
In particular, this medical device analyzes non-contrast brain CT images, and if a suspected intracranial hemorrhage is identified, it sends a notification to medical specialists, who are advised to review these images. Images may be previewed through the mobile app but are for informational purposes only and are not intended to be used for diagnostic purposes other than notifications and previews. The medical specialist who received the notification is responsible for reading the image in a diagnostic viewer.
Hyper Insight - ICH is limited to the purpose of analysis of image data and should not be used as a substitute for a full patient assessment or relied upon to make or confirm a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240353: Hyper Insight - ICH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240353
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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