AI4CMR

Organization name

AI4MedImaging Medical Solutions S.A.

SRN

PT-MF-000002951

Manufacturer status

Active

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

• CW999

  Warnings and precautions • The physician must always review the cases even when AI4CMR classifies them as normal. • Quantitative analysis is dependent on the quality and correctness of the image source data acquisition. • The patient data must be anonymized by the third-party plugin before sending it to AI4CMR. • The patient data displayed is initially derived from the DICOM information, if available. Editing these values may affect the calculations in all modules. It is the User’s responsibility to verify this data before releasing the final results. • The user can introduce patient metadata (cine, cine recompute and flow), It is the User’s responsibility to verify this data before releasing the final results. • The user is responsible for ensuring the seed point (at Flow) is placed precisely within the intended vessel region of interest and on a structure with adequate signal clarity. • The User must keep a UPS system that provides emergency power when the input power source or mains power fails. • It is the plugin maintenance team's responsibility to execute the installation procedure to validate the communication between the User and AI4CMR. • It is AI4MedImaging’s responsibility to update/do maintenance periodically to reduce the probability of AI4CMR SW defects. • At the installation time, a copy of the digital user manual must be copied to the User’s network, under the domain of the User’s IT Manager. • In the event of loss of access credentials please follow the procedure in section 4. User account handling. • Users should read this manual before using AI4CMR. Contra-indications • AI4CMR is contraindicated to be used for post-processing of all image modalities other than cine and 2D phase-encoded images of CMR.

Primary placement in Portugal; available across 6 countries total.

Trade name

not provided

UDI-DI code

05600250059039

Basic UDI-DI

5600250059SW1ZD

Reference / catalog number

AI4CMR

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

AI4CMR is an image analysis software for post-processing of cardiac magnetic resonance images (CMR), which are used for assessment of cardiac diseases. AI4CMR uses artificial intelligence and is intended to automize cardiac segmentation allowing instantaneous quantification of ventricular volumes, myocardial mass, ejection fraction of heart ventricles and to automatically assess ventricle wall motion. AI4CMR also supports clinical diagnostics by calculating flow measurements of vascular structures in 2D phase-encoded cardiac MR images.

Additional information URL

https://ai4cmr.com/support-documentation/

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12040182GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES