510(k) · Cleared
ClearedRapid Vessel Occlusion (Rapid VO)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
iSchemaview · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Jul 13, 2026 as substantially equivalent to K251151 (Ischemaview, 2025) after a 103-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Jul 13, 2026
- Review
- 103 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 5 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 4 generations backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 3 generations backK193087 Rapid ICHIschemaview Incorporated · 2020
- 2 generations backK200941 Rapid LVOIschemaview, Inc. · 2020
- 1 generation backK251151 Rapid CTA 360Ischemaview · 2025
- This deviceK261085 Rapid Vessel Occlusion (Rapid VO)iSchemaview · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −4 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| −3 | K193087 | Rapid ICH | Ischemaview Incorporated | 2020 | — |
| −2 | K200941 | Rapid LVO | Ischemaview, Inc. | 2020 | — |
| −1 | K251151 | Rapid CTA 360 | Ischemaview | 2025 | — |
| 0 (this device) | K261085 | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | 2026 | — |
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 |
|---|---|---|---|
| * | K251151 | Rapid CTA 360Summary page 5…e Device: The iSchemaview Rapid VO Triage and Notification Module is claimed to be substantially equivalent to the legally marketed predicate, iSchemaView Rapid CTA 360 (K251151). Device Description: The Rapid VO device is a radiological computer-assisted Triage and Notification Software device using AI/ML… | 2025 |
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 8 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- None of the 5 ancestors has a recall.
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. 2026, 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 VO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA adult head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion findings in head CTA images including the ICA, MCA (M1-M2), and Basilar vascular segments. Rapid VO uses an Al software algorithm to analyze images and…
Read the full statement (194 words)
Rapid VO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA adult head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion findings in head CTA images including the ICA, MCA (M1-M2), and Basilar vascular segments.
Rapid VO uses an Al software algorithm to analyze images and highlight cases with suspected occlusion on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected occlusion findings. Notifications include compressed preview images. These 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 is not intended to be used as a diagnostic device.
The results of Rapid VO 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.
Rapid VO is for use on Adults.
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/K261085 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261085: Rapid Vessel Occlusion (Rapid VO).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261085
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026