CINA-iPE

Primary DI

+B826CINAIPE100

Basic UDI-DI Code

++B826CINAIPE103M

Reference

CINA-iPE

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Avicenna.AI

CINA-iPE is a radiological computer-assisted triage and notification software device. CINA-iPE runs on a standard “off-the-shelf” server/workstation and consists of an iPE Image Processing Application, which can be integrated, deployed, and used with medical image communications devices. CINA-iPE receives contrast-enhanced CT scans (not dedicated CTPA protocol) including at least a part of the lung identified by the medical image communications device, processes them using deep learning models to identify the suspected presence of iPE, and generates results files to be transferred by the medical image communications device for output to a PACS system or workstation for worklist prioritization. The series are processed chronologically by running algorithms on each series to detect suspected positive findings of an incidental Pulmonary Embolism (iPE), and then active notifications on the flagged series are sent to the Worklist Application. The Worklist Application displays the active notification of new studies with suspected findings when they come in and provides both active and passive notifications. All the Contrast-Enhanced CT studies received by CINA-iPE device are displayed in the worklist and those on which the algorithms have detected a suspected finding are marked with an icon (i.e., active notification). In addition, a compressed, grayscale, unannotated image that is marked “not for diagnostic use” is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).