510(k) · Cleared
ClearedRapid ICH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ischemaview Incorporated · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Mar 31, 2020 as substantially equivalent to K180647 (Aidoc Medical, Ltd., 2018) after a 146-day review. Its family tree reaches back 2 generations to 2018. 7 later devices descend from it.
- Decided
- Mar 31, 2020
- Review
- 146 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170073 (2018). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 1 generation backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- This deviceK193087 Rapid ICHIschemaview Incorporated · 2020
- Descendant · cites it directly · 3 of its ownK200941 Rapid LVOIschemaview, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK221456 Rapid ICHIschemaview, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK251151 Rapid CTA 360Ischemaview · 2025
- Descendant · 2 generations on · 1 of its ownK232436 Rapid SDHIschemaview, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK261085 Rapid Vessel Occlusion (Rapid VO)iSchemaview · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K200941Rapid LVOIschemaview, Inc. · 2020 · cites it directly3descendants
- K221456Rapid ICHIschemaview, Inc. · 2022 · cites it directly2descendants
- K251151Rapid CTA 360Ischemaview · 2025 · 2 generations on1descendant
- K232436Rapid SDHIschemaview, Inc. · 2023 · 2 generations on1descendant
- K261085Rapid Vessel Occlusion (Rapid VO)iSchemaview · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −1 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| 0 (this device) | K193087 | Rapid ICH | Ischemaview Incorporated | 2020 | — |
| +1 | K200941 | Rapid LVO | Ischemaview, Inc. | 2020 | — |
| +1 | K221456 | Rapid ICH | Ischemaview, Inc. | 2022 | — |
| +2 | K251151 | Rapid CTA 360 | Ischemaview | 2025 | — |
| +2 | K232436 | Rapid SDH | Ischemaview, Inc. | 2023 | — |
| +3 | K261085 | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K180647 | BriefCaseSummary page 4…Panel: Predicate Devices: The iSchemaView RAPID ICH is claimed to be substantially equivalent to the following legally marketed predicate device: Aidoc’s BriefCase (K180647). Device Description: RAPID ICH is a clinical module which operates within the integrated RAPID Platform to provide triage and… | 2018 |
What descends from it? (7)
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 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K200941 (Ischemaview, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 11 other devices also cite its predicate K180647.
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 ICH is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH). RAPID ICH uses an artificial intelligence algorithm to analyze images and highlight…
Read the full statement (181 words)
RAPID ICH is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images.
The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH).
RAPID ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH 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 ICH 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 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 clinicians 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/K193087 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193087: Rapid ICH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193087
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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