# K192167: CuraRad-ICH

- Pathway: 510(k) (Traditional)
- Applicant: Curacloud Corp.
- Decided: Apr 13, 2020 after 248 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: 2 generations back to DEN170073 (2018). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182177: Accipiolx, Maxq-Al, Ltd. (2018) Summary page 4.

## Most influential descendants
- K231025: EFAI NeuroSuite CT ICH Assessment System (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K192167
Methodology: https://510kreport.com/methodology