# K233968: CINA-iPE

- Pathway: 510(k) (Traditional)
- Applicant: Avicenna.Ai
- Decided: Mar 13, 2024 after 89 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: 6 generations back to DEN170073 (2018). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213886: BriefCase, Aidoc Medical, Ltd. (2022) Summary page 4.

## Indications for use
CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the lung. The device is intended to assist hospital networks and appropriately trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults). CINA-iPE uses an artificial intelligence algorithm to analyze images and highlight cases with detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings.The device is not designed to detect PE in subsegmental arteries. 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-iPE are intended to be used in conjunction with other patient information and based on their 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/K233968
Methodology: https://510kreport.com/methodology