510(k) · Cleared
ClearedCuraRad-ICH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curacloud Corp. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Apr 13, 2020 as substantially equivalent to K182177 (Maxq-Al, Ltd., 2018) after a 248-day review. Its family tree reaches back 2 generations to 2018. 1 later device descends from it.
- Decided
- Apr 13, 2020
- Review
- 248 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170073 (2018). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K231025EFAI NeuroSuite CT ICH Assessment SystemEver Fortune.Ai, Co., Ltd. · 2023 · cites it directly0descendants
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 | K182177 | Accipiolx | Maxq-Al, Ltd. | 2018 | — |
| 0 (this device) | K192167 | CuraRad-ICH | Curacloud Corp. | 2020 | — |
| +1 | K231025 | EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.Ai, Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K182177 | AccipiolxSummary page 4…lassification Name: Radiological Computer-Assisted Triage and Notification Software Regulatory Class: Class II Product Code: QAS Predicate Device: MaxQ-AI Ltd. Accipolx (K182177). Device Description CuraRad-ICH is software as a medical device (SaMD) that detects intracranial hemorrhage (ICH… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231025 | EFAI NeuroSuite CT ICH Assessment System | 2023 | 0 |
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 1.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231025 (Ever Fortune.Ai, Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K182177.
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?
CuraRad-ICH is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage. CuraRad-ICH analyzes cases using deep learning algorithms to identify suspected ICH findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage.
CuraRad-ICH is not intended to direct attention to specific portions of an image or to anomalies other than acute ICH. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192167: CuraRad-ICH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192167
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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