FDA-cleared profile

1CMR Pro

Mycardium AI Limited

1CMR Pro displays, analyzes, and transfers DICOM cardiovascular images acquired in CMR scanners, including multi-slice, multi-phase, multi-parametric, and velocity-encoded CMR images of the heart and major vessels. The FDA material describes use with 1.5T and 3T CMR scanners and support for healthy subjects and patients with suspected cardiac disease.

Cardiac imaging

Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose: 1CMR Pro displays, analyzes, and transfers DICOM cardiovascular images acquired in CMR scanners, including multi-slice, multi-phase, multi-parametric, and velocity-encoded CMR images of the heart and major vessels. The FDA material describes use with 1.5T and 3T CMR scanners and support for healthy subjects and patients with suspected cardiac disease.

Intended users: Qualified healthcare professionals trained for the exact represented anatomy, modality, and workflow.

Care setting and population: Hospital, clinic, imaging-center, procedural, dental, or other labeled clinical environments.

Workflow role: Medical-image processing, segmentation, enhancement, measurement, quantification, visualization, or reporting support under professional review.

Required input: Supported medical images, DICOM metadata, patient and protocol information, and release-specific user inputs.

Output and human action: Images, segmentations, measurements, models, calculations, overlays, or reports that require professional review.

Limitations: The FDA indication excludes known congenital cardiac abnormalities, children under 18 years, and patients with pacemakers, including MR-compatible pacemakers. Interpretation and patient-management decisions remain with qualified professionals.

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission: K242062

Modality: MRI

Anatomy: Heart/cardiovascular structures and major vessels

Clearance type: 510(k)

Decision date: 2024-11-15

FDA status: FDA-cleared

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration: Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.

Deployment and data flow: Not established in reviewed sources

Security and privacy: Not established in reviewed sources

Training and support: Only qualified healthcare professionals trained for the exact represented anatomy, modality, and workflow should operate or interpret this product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.

Monitoring and change control: Monitor by exact hardware, software, model, algorithm, reconstruction, or configuration version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: The FDA indication excludes known congenital cardiac abnormalities, children under 18 years, and patients with pacemakers, including MR-compatible pacemakers. Interpretation and patient-management decisions remain with qualified professionals.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K242062 before acceptance. Later family features are not evidence for this exact submission.

exact submission · checked 2026-09-04

Source

Interoperability acceptance

The exact FDA material does not establish a complete interoperability contract. Establish and test supported input, output, identity, routing, archive, and downtime behavior locally.

exact submission · checked 2026-09-04

Source

Deployment and security qualification

The exact FDA material does not establish hosting, deployment topology, availability, upgrade path, or service responsibility. Obtain site-specific evidence before procurement.

exact submission · checked 2026-09-04

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The FDA indication excludes known congenital cardiac abnormalities, children under 18 years, and patients with pacemakers, including MR-compatible pacemakers. Interpretation and patient-management decisions remain with qualified professionals.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs. No exact-product price was found.

product family · checked 2026-09-04

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, algorithm, reconstruction, or configuration version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: The FDA indication excludes known congenital cardiac abnormalities, children under 18 years, and patients with pacemakers, including MR-compatible pacemakers. Interpretation and patient-management decisions remain with qualified professionals.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

Source Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary: The exact FDA 510(k) decision material for K242062 identifies 1CMR Pro and describes the indicated use summarized in this dossier. It is regulatory evidence for the exact submission, not independent clinical validation. No performance or outcome claim is promoted without exact product and version linkage.

Reported sensitivity: Not applicable

Reported specificity: Not applicable

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K242062 FDA decision evidence for 1CMR Pro

FDA 510(k) substantial-equivalence review of the exact submission, device description, indications, and verification or validation documentation. · Heart/cardiovascular structures and major vessels

exact submission · Tested version: 1CMR Pro · Sponsor or vendor study

K242062

The FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.

Source

Economics and lifecycle

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost: Not established in reviewed sources

Reimbursement and coding: No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, surgical, or diagnostic service line and verify payer, site-of-service, and coding assumptions independently.

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review: The 2026-09-02 openFDA device-recall snapshot contained no record matched to K242062 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.

Buyer worksheet

Open questions to take to the vendor

Verify deployment and data flow: The exact FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
Verify security and privacy controls: Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Verify pricing and total cost: No public list price for the exact cleared or approved configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus

2026-09-04Last searched

32Fields reviewed

10Source classes checked

0Unreviewed PubMed leads

0Unreviewed trial leads

0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact-name and exact-submission searches in the checked indexes returned no PubMed records and no ClinicalTrials.gov records for K242062; no published exact-submission recall was promoted. Candidate literature, registry, and non-native recall records remain quarantined unless exact product, version, and submission linkage is established. The FDA decision material remains the identity and intended-use anchor for 1CMR Pro. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-04.

FDA 510(k) decision material K242062: 1CMR Pro U.S. Food and Drug Administration · 2026-09-04
Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02

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