Radiology AI Directory

FDA-cleared profile

LARALAB

LARALAB GmbH

Authorized purpose: Cardiac CT segmentation, measurement and valve-intervention planning

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: Cardiac CT segmentation, measurement and valve-intervention planning

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Cardiac CT segmentation, measurement and valve-intervention planning

Evidence takeaway

Evidence from the reviewed source record: Multicenter standalone observational evaluation of 60 CT cases, divided equally across aortic, mitral and tricuspid planning; expert manual measurements using 3mensio served as comparator. Patients were aged 62-97; 45% were male.

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
Cardiac CT segmentation, measurement and valve-intervention planning
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Cardiologists, radiologists, heart surgeons and healthcare professionals
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adult cardiovascular intervention and surgery planning
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Validation patients were 62-97 years old; this is not evidence for all adult subgroups.

Workflow role
Segmentation or contouring; measurement and planning support
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
DICOM-compliant CT images of heart and vessels for aortic, mitral and tricuspid valve intervention planning
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Cardiovascular and calcification segmentations; splines, distances, angulation and volume measurements; MPR and surface-rendered views; assessments and PDF planning reports
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
Automated segmentations and measurements can be reviewed and adjusted manually. Clinical validation described patients aged 62 and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
K242500
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Heart/Cardiovascular
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-04-16
  • 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
Users upload deidentified local DICOM files and export PDF reports
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Native PACS import in the predicate comparison must not be attributed to the subject device.

Deployment and data flow
On-cloud
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

FDA-described access/encryption controls are not a current scoped security certification. Hosting region, retention, contractual data controls and dated attestations were not established.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

User qualification requirements beyond intended-user categories and the contracted onboarding package remain to be confirmed.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Site acceptance should address segmentation corrections and report transfer; this is editorial guidance, not a verified monitoring capability.

Current family viewer

Vendor describes a cloud-based heart.ai workflow with a 4D DICOM viewer

product family · checked 2026-09-05

Some advertised features are marked research use only; the current feature set is not equated with K242500.

Source

Manual correction

Manual measurement and adjustment of automated planning results

exact submission · checked 2026-09-05
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
Multicenter standalone observational evaluation of 60 CT cases, divided equally across aortic, mitral and tricuspid planning; expert manual measurements using 3mensio served as comparator. Patients were aged 62-97; 45% were male.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

Reviewed measurement-comparison evidence does not establish a general diagnostic sensitivity.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

A diagnostic specificity was not established in the reviewed planning study.

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

K242500 cardiac CT planning performance study

  • DesignMulticenter observational standalone comparison against expert 3mensio measurements
  • Population20 aortic, 20 mitral and 20 tricuspid CT cases; age 62-97
  • Scopeexact submission
  • Tested versionLARALAB evaluated in K242500
  • Samplen=60
  • IndependenceIndependence not established

K242500

Source

Staged transcatheter mitral and tricuspid valve replacement case report

  • DesignClinical case report with LARALAB planning-tool image
  • PopulationOne 79-year-old man undergoing staged Tendyne mitral and MonarQ tricuspid procedures
  • Scopeproduct family
  • Tested versionLARALAB online planning tool; version unspecified
  • Samplen=1
  • IndependenceIndependence not established

PMID:40155128 · doi:10.1016/j.jaccas.2025.103534

Figure identifies LARALAB use; not a software-accuracy study or causal evidence of benefit.

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 2026-09-05

Reviewed vendor pages did not establish a dated exact-version license or planning-case rate.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-05

No applicable payer policy for this planning software was reviewed.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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.

Human reviewedStatus
2026-09-05Last searched
20Fields reviewed
11Source classes checked
1Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

PMID40155128 identifies the family planning tool in a single case and is retained contextually. NCT06951126 stored metadata concerns CT prediction for transcatheter tricuspid interventions; exact product/version applicability remains unestablished. Registry page returned a JavaScript shell; no trial outcomes promoted. The current discovery snapshot contains 1 PubMed and 1 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, vendor product page, literature index, peer reviewed publication, trial registry, recall database, 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. K242500 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. LARALAB GmbH model card (K242500)

    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. LARALAB: K242500 decision and 510(k) summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: identity, clinical, evidence, implementation

  8. LARALAB heart.ai

    LARALAB - Accessed 2026-09-05

    Scope: implementation

  9. Staged transcatheter mitral and tricuspid valve replacement case report

    JACC Case Reports / PubMed - Published 2025-03-19 - Accessed 2026-09-05

    Scope: evidenceStudies

Research history

  1. K242500 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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Decision
2025-11-28
Cardiac imagingQuantification and segmentation