# K182177: Accipiolx

- Pathway: 510(k) (Traditional)
- Applicant: Maxq-Al, Ltd.
- Decided: Oct 26, 2018 after 77 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170073 (2018). 1 ancestor in all.
7 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170073: ContaCT, Viz.Al, Inc. (2018) Summary page 4.

## Most influential descendants
- K203260: syngo.CT Brain Hemorrhage (2022), 2 descendants of its own
- K232431: syngo.CT Brain Hemorrhage (2024), 1 descendant of its own
- K192167: CuraRad-ICH (2020), 1 descendant of its own
- K243145: syngo.CT LVO Detection (2025), 0 descendants of its own
- K231025: EFAI NeuroSuite CT ICH Assessment System (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K182177
Methodology: https://510kreport.com/methodology