N/A

Organization name

Methinks Software SL

SRN

ES-MF-000023690

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  Identification of suspected findings is not for diagnostic use beyond notification. Methinks Stroke Suite is limited to analysis of imaging data and should not be used in- lieu of full patient evaluation or relied upon to make or confirm diagnosis. Key Images provided through the notification module are for informational purposes only and not intended for diagnostic use beyond notification.For non-enhanced images, NCCT-LVO and NCCT-ICH, soft tissue reconstruction kernels must be used.

Primary placement in Spain; available across 3 countries total.

Trade name

not provided

UDI-DI code

08437023475027

Basic UDI-DI

8437023475MSSEUBH

Reference / catalog number

N/A

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

https://www.methinks.ai/instruction-for-use

Clinical sizes

No clinical sizes registered for this device.

• Z11030582RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification