510(k) · Cleared
ClearedRapid LVO
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 Jul 9, 2020 as substantially equivalent to K193087 (Ischemaview Incorporated, 2020) after a 92-day review. Its family tree reaches back 3 generations to 2018. 3 later devices descend from it.
- Decided
- Jul 9, 2020
- Review
- 92 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 2 generations backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 1 generation backK193087 Rapid ICHIschemaview Incorporated · 2020
- This deviceK200941 Rapid LVOIschemaview, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK251151 Rapid CTA 360Ischemaview · 2025
- Descendant · 2 generations on · 0 of its ownK261085 Rapid Vessel Occlusion (Rapid VO)iSchemaview · 2026
- Descendant · cites it directly · 0 of its ownK221248 Rapid LVOIschemaview, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView 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 | K193087 | Rapid ICH | Ischemaview Incorporated | 2020 | — |
| 0 (this device) | K200941 | Rapid LVO | Ischemaview, Inc. | 2020 | — |
| +1 | K251151 | Rapid CTA 360 | Ischemaview | 2025 | — |
| +2 | K261085 | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | 2026 | — |
| +1 | K221248 | Rapid LVO | Ischemaview, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K193087 | Rapid ICHSummary page 4…Predicate Devices: The iSchemaView Rapid LVO is claimed to be substantially equivalent to the following legally marketed predicate device: iSchemaView Rapid ICH (K193087) Device Description: Rapid LVO 1.0 is a clinical module which operates within the integrated Rapid Platform to provide triage an… | 2020 |
What descends from it? (3)
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 2 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K251151 (Ischemaview, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K193087.
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. 2020, 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 LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion (LVO) findings in head CTA images. Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO on a server or standalone…
Read the full statement (279 words)
Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion (LVO) findings in head CTA images.
Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO 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 LVO findings. Notifications include compressed preview images, that are meant for informational purposes only and 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 LVO 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.
Contraindications/Exclusions/Cautions:
• Rapid LVO is one input to physician diagnosis for patients undergoing screening for acute ischemic stroke.
• Excessive patient motion may lead to artifacts that make the scan technically inadequate.
• Identification of suspected findings is not for diagnostic use beyond notification. Images that are previewed through email and the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification.
• Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200941: Rapid LVO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200941
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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