# K250694: Scaida BrainCT-ICH (v1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Mlhealth 360
- Decided: Nov 25, 2025 after 263 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: 3 generations back to DEN170073 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211179: InferRead CT Stroke.AI, Infervision Medical Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
Scaida BrainCT-ICH is a radiological computer aided notification software indicated for use in the analysis of non-contrast head CT images of adult patients (ages 22 and above). The device is intended to assist trained radiologists in workflow triage by flagging and communicating suspected positive findings of pathologies in head CT images, for Intracranial Hemorrhages (ICH). The suspected ICH could be part of any of these five subtypes: Intraparenchymal hemorrhage (IPH), Intraventricular hemorrhage (IVH), Subarachnoid hemorrhage (SAH), Subdural hemorrhage (SDH), and Epidural Hemorrhage (EDH). The Scaida BrainCT-ICH device does not provide this ICH subclassification to the user; it uses an artificial intelligence algorithm to analyze images, and it identifies cases with suspected ICH only. The device does not alter the original medical image, does not remove cases from the queue, and is not intended to be used as a diagnostic device or for use in patients under 22 years of age. If the clinician does not view the case, or if a case is not flagged, cases remain to be processed per the standard of care. The results of Scaida BrainCT-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 radiologists are responsible for viewing full images per the standard of care.

Source page: https://510kreport.com/device/K250694
Methodology: https://510kreport.com/methodology