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Diagnostic imaging

1CMR Pro

Mycardium AI Limited

1CMR Pro is cataloged as an AI-enabled diagnostic imaging product associated with radiology, cardiac, mr workflows. Source records identify Mycardium AI Limited as the associated developer or manufacturer.

Designed for

Radiologist and clinical team

Care setting

Imaging department and relevant care setting

Specialty

Radiology, Cardiac, MR

Catalog record · evidence not yet assessedCatalog updated 2026-08-31

Catalog status

Evidence not yet characterized

This catalog entry is based on 2 public source records. RIR has not yet characterized the product's clinical evidence.

This is a catalog and scoping record. RIR has not completed a public-evidence assessment of this product. Inclusion is not endorsement, verification, certification, or a recommendation.

What the source record supports

The linked sources support catalog inclusion and identify the product and associated organization. They do not constitute an RIR evidence assessment.

What still needs verification

Current product-family mapping, exact intended use and version, present availability, independent performance, subgroup behavior, workflow effects, safety monitoring, and patient outcomes may remain unresolved.

Product facts

Working intended-use description
Support radiologist and clinical team with aortic measurements, contouring with manual edit capability (human-in-the-loop), explainable AI (visible contours) in imaging department and relevant care setting.
Intended-use status
Drafted from structured source metadata; official labeling still required
Represented version
Public sources accessed 2026-08-31; represented software version not established
Regulatory context
FDA's AI-Enabled Medical Device List contains 1 record for this candidate (K242062); the latest listed decision date is 2024-11-15. Product-family mapping, current marketing status, and the exact authorized scope require decision-record review.

Sources represented

2 source records used to identify or scope this catalog entry.

FDA authorization record K242062RegulatoryHealth AI Register: 1CMR ProDirectory / registry
For clinical and investment reviewEvidence context and questions for deeper review

Current source base

This catalog entry is based on 2 public source records. RIR has not yet characterized the product's clinical evidence.

Important limitation

Current product-family mapping, exact intended use and version, present availability, independent performance, subgroup behavior, workflow effects, safety monitoring, and patient outcomes may remain unresolved.

Questions to ask

  1. 01How does performance vary across sites, scanners, protocols, and patient subgroups?
  2. 02What are the clinically consequential false-positive and false-negative rates?
  3. 03How are performance drift, overrides, and product updates monitored after deployment?
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