AI4CMR

GUDID 05600250059022

AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion Indications for use: AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.

AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.

MRI system application software

• Primary Device ID: 05600250059022
• NIH Device Record Key: c7a09408-f149-4e3f-916c-1e0c7571a7f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AI4CMR
• Version Model Number: v1.0
• Company DUNS: 449341503
• Company Name: AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05600250059022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220624

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-12
• Device Publish Date: 2023-01-04