Radiology AI Directory

FDA-cleared profile

TeraRecon Cardiac.Chambers.MR (1.0.0)

TeraRecon,Inc.

Authorized purpose: Provide cardiac-chamber segmentations for trained healthcare professionals reviewing adult cardiac MR to assist diagnosis or treatment planning; the physician makes final patient-management decisions.

Cardiac imagingQuantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: Provide cardiac-chamber segmentations for trained healthcare professionals reviewing adult cardiac MR to assist diagnosis or treatment planning; the physician makes final patient-management decisions.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Provide cardiac-chamber segmentations for trained healthcare professionals reviewing adult cardiac MR to assist diagnosis or treatment planning; the physician makes final patient-management decisions.

Evidence takeaway

Evidence from the reviewed source record: FDA K241312 reports a retrospective validation cohort of 100 adults split into 50 Cine-ax and 50 De-ax patients, with ground truth reviewed by a board-certified radiologist. Cine-ax mean Dice scores were 0.82 (95% CI 0.81-0.83) for LV myocardium, at least 0.90 (0.89-0.91) for LV chamber, and 0.84 (0.82-0.85) for RV chamber. De-ax mean Dice scores were 0.79 (0.75-0.83) for LV myocardium and 0.88 (0.84-0.92) for LV chamber. The packet reports acceptance criteria were met across stated subgroups.

Clinical details

What this tool is for

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

Exact purpose
Provide cardiac-chamber segmentations for trained healthcare professionals reviewing adult cardiac MR to assist diagnosis or treatment planning; the physician makes final patient-management decisions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Trained healthcare professionals, including physicians experienced in examining and evaluating cardiovascular MR images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Adult cardiac MR procedure and post-processing workflow; facility type is not specified in the FDA packet.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Cardiac MR post-processing segmentation aid for chamber delineation and downstream review or planning.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Contrast or non-contrast DICOM-compliant cardiovascular MR images from adults. Cine-ax uses 4D multiphase GRE and De-ax uses 3D multi-slice IR single-phase data; the validation cohort used GE, Philips, and Siemens scanners with cardiac gating and breath synchronization.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
DICOM files containing Cine-ax LV myocardium, LV chamber, and RV chamber segmentations, and De-ax LV myocardium and LV chamber segmentations, for use in DICOM-compliant viewers such as TeraRecon Intuition or PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Adult cardiac MR use is labeled; contrast or non-contrast DICOM cardiac MR input and the supported component-specific sequences are required. The physician remains responsible for final management decisions, and exact local sequence/interface compatibility requires confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K241312
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Cardiac chambers: left-ventricular myocardium and chamber, and right-ventricular chamber for the Cine-ax component; left-ventricular myocardium and chamber for the De-ax component.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-11-05
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

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

Integration
Containerized deployment and DICOM-compliant input/output are described; output files may be used by TeraRecon Intuition, PACS, or other DICOM-compliant systems. Exact interface versions and local routing behavior are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for TeraRecon Cardiac.Chambers.MR (1.0.0); FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
FDA K241312 reports a retrospective validation cohort of 100 adults split into 50 Cine-ax and 50 De-ax patients, with ground truth reviewed by a board-certified radiologist. Cine-ax mean Dice scores were 0.82 (95% CI 0.81-0.83) for LV myocardium, at least 0.90 (0.89-0.91) for LV chamber, and 0.84 (0.82-0.85) for RV chamber. De-ax mean Dice scores were 0.79 (0.75-0.83) for LV myocardium and 0.88 (0.84-0.92) for LV chamber. The packet reports acceptance criteria were met across stated subgroups.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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

TeraRecon Cardiac.Chambers.MR (1.0.0) regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K241312
  • Samplen=100
  • IndependenceIndependence not established

K241312

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Costs and setup

Budget and ongoing governance

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

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K241312 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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 exact-identifier FDA recall query returned no native recall record for K241312. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

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

Exact FDA record reviewedStatus
2026-09-20Last searched
22Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K241312: TeraRecon Cardiac.Chambers.MR (1.0.0)

    U.S. Food and Drug Administration - Published 2024-11-05 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. TeraRecon Cardiac.Chambers.MR (1.0.0) model card (K241312)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K241312

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K241312 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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