510(k) · Cleared
ClearedRapid NCCT Stroke
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ischemaview, Inc. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Mar 2, 2023 as substantially equivalent to K200855 (Avicenna.Ai, 2020) after a 161-day review. Its family tree reaches back 3 generations to 2018. 5 later devices descend from it.
- Decided
- Mar 2, 2023
- Review
- 161 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 2 generations backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 1 generation backK200855 CINAAvicenna.Ai · 2020
- This deviceK222884 Rapid NCCT StrokeIschemaview, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK232496 Brainomix 360 Triage StrokeBrainomix Limited · 2023
- Descendant · cites it directly · 0 of its ownK252421 JLK-NCCTJLK, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253818 Annalise EnterpriseHarrison-AI Medical Pty, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251983 Brainomix 360 Triage StrokeBrainomix Limited · 2025
- Descendant · cites it directly · 0 of its ownK250685 Methinks NCCT StrokeMethinks Software, S.L · 2025
Most influential descendants
Showing 5 of 5 · See all- K232496Brainomix 360 Triage StrokeBrainomix Limited · 2023 · cites it directly1descendant
- K252421JLK-NCCTJLK, Inc. · 2026 · cites it directly0descendants
- K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd. · 2026 · cites it directly0descendants
- K251983Brainomix 360 Triage StrokeBrainomix Limited · 2025 · 2 generations on0descendants
- K250685Methinks NCCT StrokeMethinks Software, S.L · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −2 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| −1 | K200855 | CINA | Avicenna.Ai | 2020 | — |
| 0 (this device) | K222884 | Rapid NCCT Stroke | Ischemaview, Inc. | 2023 | — |
| +1 | K232496 | Brainomix 360 Triage Stroke | Brainomix Limited | 2023 | — |
| +1 | K252421 | JLK-NCCT | JLK, Inc. | 2026 | — |
| +1 | K253818 | Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | 2026 | — |
| +2 | K251983 | Brainomix 360 Triage Stroke | Brainomix Limited | 2025 | — |
| +1 | K250685 | Methinks NCCT Stroke | Methinks Software, S.L | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K200855 | CINASummary page 5…el: Predicate Devices: The Rapid NCCT Stroke device is claimed to be substantially equivalent to the following legally marketed predicate device: Avicenna’s CINA device (K200855). Device Description: Rapid NCCT Stroke (RNS) is a radiological computer-assisted triage and notification software device. RNS i… | 2020 |
What descends from it? (5)
4 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 5 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232496 (Brainomix Limited, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K200855.
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. 2023, 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?
Rapid NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) NCCT large vessel occlusion (LVO) of the ICA and MCA-M1. Rapid NCCT Stroke uses an…
Read the full statement (358 words)
Rapid NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) NCCT large vessel occlusion (LVO) of the ICA and MCA-M1.
Rapid NCCT Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) NCCT LVO on the Rapid server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings via PACS, email or mobile device. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification.
The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Rapid NCCT Stroke 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 ultimately responsible for reviewing full images per the standard of care. Rapid NCCT Stroke is for Adults only.
Cautions:
• All patients should get adequate care for their symptoms including CTA and/or other appropriate care per the standard clinical practice, irrespective of the device output.
• The device is not intended to be a rule-out device and for cases that have been processed by the device without notification for “Suspected LVO” should not be viewed as indicating that LVO is excluded. All cases should undergo CTA, per the standard stroke workup.
Limitations:
• Rapid NCCT Stroke does not replace the need for CTA or MRA in ischemic stroke workup, it provides workflow prioritization and notification only.
• Rapid ICH has been shown to reliably identify hemorrhages of ≥ 0.4ml.
Contraindications/Exclusions
• Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.
• Hemorrhagic Transformation, Hematoma
• Very thin or no Ventricles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222884: Rapid NCCT Stroke.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222884
Report an extraction error
Are you the manufacturer?
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