Methinks Stroke Suite

Primary DI

08437023475010

Basic UDI-DI Code

8437023475MSSEUBH

Reference

N/A

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Methinks Software SL

Intended Use: Methinks Stroke Suite is a radiological computer aided triage and notification system indicated for use in the analysis of Non-Contrast Computed Tomography (NCCT) images and Computed Tomography Angiography (CTA) images of the head. The device is intended to assist trained physicians in workflow triage by notification of suspected positive cases of Acute Intracranial Hemorrhage (ICH) and Large Vessel Occlusion (LVO) in emergency settings. It works in parallel with the ongoing standard of care image interpretation and the result of the device shall be used in conjunction with other patient information and based on professional judgement. The device shall not be used for full patient evaluation or relied upon to make or confirm the diagnosis. It shall be used to alert physicians about a high probability of stroke-related findings (Large Vessel Occlusion (LVO) and/or acute Intracranial Hemorrhage (ICH)) in order to prioritize the study reading. The product is limited to analysis of imaging for the narrow detection of Acute Stroke (AS) findings, and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.

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