510(k) · Cleared
ClearedAccipiolx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxq-Al, Ltd. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Oct 26, 2018 as substantially equivalent to DEN170073 (Viz.Al, Inc., 2018) after a 77-day review. Its family tree reaches back 1 generation to 2018. 7 later devices descend from it.
- Decided
- Oct 26, 2018
- Review
- 77 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170073 (2018). 7 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN170073 ContaCTViz.Al, Inc. · 2018
- This deviceK182177 AccipiolxMaxq-Al, Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK203260 syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK232431 syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK192167 CuraRad-ICHCuracloud Corp. · 2020
- Descendant · 3 generations on · 0 of its ownK243145 syngo.CT LVO DetectionSiemens Medical Solutions USA, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK231025 EFAI NeuroSuite CT ICH Assessment SystemEver Fortune.Ai, Co., Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K203260syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc. · 2022 · cites it directly2descendants
- K232431syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc. · 2024 · 2 generations on1descendant
- K192167CuraRad-ICHCuracloud Corp. · 2020 · cites it directly1descendant
- K243145syngo.CT LVO DetectionSiemens Medical Solutions USA, Inc. · 2025 · 3 generations on0descendants
- K231025EFAI NeuroSuite CT ICH Assessment SystemEver Fortune.Ai, Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| 0 (this device) | K182177 | Accipiolx | Maxq-Al, Ltd. | 2018 | — |
| +1 | K203260 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +2 | K232431 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +1 | K192167 | CuraRad-ICH | Curacloud Corp. | 2020 | — |
| +3 | K243145 | syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | DEN170073 | ContaCTSummary page 4…Triage and Notification Software Regulatory Class: Class II Regulatory Classification and Product Code: 21 C.F.R. § 892.2080; QAS Predicate Device: ContaCT (Viz.AI), DEN170073 Reference Device: AiDoc Briefcase (K180647) Device Description AccipioIx is a software device designed to be installed within h… | 2018 |
| † | K180647 | BriefCase | 2018 |
What descends from it? (7)
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?
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. 2018, 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?
Accipiolx 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 in the acute care environment. Accipiolx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. Accipiolx is not intended to direct…
Read the full statement (109 words)
Accipiolx 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 in the acute care environment. Accipiolx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage.
Accipiolx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. 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 cases.
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/K182177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182177: Accipiolx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182177
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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