# K200855: CINA

- Pathway: 510(k) (Traditional)
- Applicant: Avicenna.Ai
- Decided: Jun 24, 2020 after 85 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.
8 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180647: BriefCase, Aidoc Medical, Ltd. (2018) Summary page 4.

## Most influential descendants
- K222884: Rapid NCCT Stroke (2023), 5 descendants of its own
- K232496: Brainomix 360 Triage Stroke (2023), 1 descendant of its own
- K221716: CINA (2022), 1 descendant of its own
- K252421: JLK-NCCT (2026), 0 descendants of its own
- K253818: Annalise Enterprise (2026), 0 descendants of its own

## Indications for use
CINA is a radiological computer aided triage and notification software indicated for use in the analysis of (1) non-enhanced head CT images and (2) CT angiographies of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) CT angiographies of the head for large vessel occlusion (LVO). CINA uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. The results of CINA 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 clinicians are ultimately responsible for reviewing full images per the standard of care.

Source page: https://510kreport.com/device/K200855
Methodology: https://510kreport.com/methodology