Mycardium 1CMR Pro

GUDID 05061038730036

1CMR Pro is software that displays, analyses and transfers DICOM cardiovascular images acquired in Cardiovascular Magnetic Resonance (CMR) scanners, specifically structure, function and flow in the heart and major vessels using multi-slice, multi-phase, multi-parametric and velocity encoded CMR images. It is compatible with 1.5T and 3T CMR acquisitions

MYCARDIUM AI LIMITED

MRI image interpretive software

• Primary Device ID: 05061038730036
• NIH Device Record Key: 675a292c-b741-4472-b0eb-5c4ea8ec5004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mycardium
• Version Model Number: 010002
• Catalog Number: 1CMR Pro
• Company DUNS: 228840878
• Company Name: MYCARDIUM AI LIMITED
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05061038730036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242062

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: 2025-04-28
• Device Publish Date: 2025-04-20

On-Brand Devices [Mycardium]

• 05061038730036: 1CMR Pro is software that displays, analyses and transfers DICOM cardiovascular images acquired
• 05061038730050: EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic