Radiology AI Directory

FDA-cleared profile

ADAS 3D

Adas3D Medical S.L

Authorized purpose: ADAS 3D provides visualization, analysis, and quantification of MR and CT heart images in individual patients with cardiovascular disease, including myocardial scar assessment for pre-planning and during electrophysiology procedures.

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: ADAS 3D provides visualization, analysis, and quantification of MR and CT heart images in individual patients with cardiovascular disease, including myocardial scar assessment for pre-planning and during electrophysiology procedures.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: ADAS 3D provides visualization, analysis, and quantification of MR and CT heart images in individual patients with cardiovascular disease, including myocardial scar assessment for pre-planning and during electrophysiology procedures.

Evidence takeaway

Evidence from the reviewed source record: K240791 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for ADAS 3D. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.

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
ADAS 3D provides visualization, analysis, and quantification of MR and CT heart images in individual patients with cardiovascular disease, including myocardial scar assessment for pre-planning and during electrophysiology procedures.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified cardiologists, electrophysiologists, radiologists, and trained technicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Cardiology, electrophysiology, and radiology workflows involving cardiovascular MR and CT.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Cardiac image post-processing and myocardial-scar assessment for clinical review and EP planning.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
DICOM enhanced cardiovascular MR and CT angiography images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Visualizations and quantitative myocardial-fibrosis, cardiac-structure, and procedure-planning results exportable in supported standard formats.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The FDA labeling states that clinical significance for arrhythmia substrate and risk stratification is not established and that the output is not an irrefutable basis or medical advice. Qualified users must interpret the results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K240791
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiological images; modality varies or is not specified in FDA list
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Heart; myocardial scar and cardiovascular structures
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-09-09
  • 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
The FDA package describes DICOM enhanced MR and CT input and export in industry-standard formats supported by catheter-navigation systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Deployment and data flow
The FDA package describes stand-alone software with supported Linux and Windows operating systems; current hosting, service, security, and site configuration remain unknown.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Use by qualified cardiologists, electrophysiologists, radiologists, and trained technicians. Follow the exact labeling, local training, supervision, and escalation requirements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K240791.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Release and scope verification

Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K240791.

exact submission · checked 2026-09-04
Source

Deployment boundary

The FDA package describes stand-alone software with supported Linux and Windows operating systems; current hosting, service, security, and site configuration remain unknown.

exact submission · checked 2026-09-04
Source

Interoperability acceptance

The FDA package describes DICOM enhanced MR and CT input and export in industry-standard formats supported by catheter-navigation systems.

exact submission · checked 2026-09-04
Source

Clinical acceptance

Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K240791.

exact submission · checked 2026-09-04
Source

Economic evaluation

Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.

product family · checked 2026-09-04
Source

Lifecycle monitoring

Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.

exact submission · checked 2026-09-04
SourceSource

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
K240791 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for ADAS 3D. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.

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

K240791 FDA evidence package for ADAS 3D

  • DesignFDA 510(k) decision evidence and product verification for the exact submission.
  • PopulationHeart; myocardial scar and cardiovascular structures
  • Scopeexact submission
  • Tested versionADAS 3D
  • IndependenceSponsor or vendor study

K240791

FDA-submitted evidence for the exact decision; it is not independent clinical validation and does not establish local production qualification.

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

No public list price or commercial contract for the exact submission and version was identified.

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

No exact-product payer coverage or reimbursement determination was identified in reviewed public material.

No product-specific code

No exact-product reimbursement determination identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.

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
No record matched K240791 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

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
2026-09-04Last searched
27Fields reviewed
11Source classes checked
20Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads

No evidence was promoted. Two PubMed records name ADAS 3D but do not identify the tested software version or K240791; the remaining records are generic cardiac-imaging evidence, other products, or unlinked trials. The current discovery snapshot contains 20 PubMed and 6 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 decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 510(k) decision material K240791: ADAS 3D

    U.S. Food and Drug Administration - Published 2024-09-09 - Accessed 2026-09-04

    Scope: identity, submission_linkage, modality, anatomy, clinical_use, intended_users, care_setting, workflow_role, input, output, limitations, evidence

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Adas 3D model card (K240791)

    American College of Radiology - Published 2026-07-08 - Accessed 2026-09-01

    Scope: intendedUsers, 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. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K240791 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

Alternatives

Related tools to compare

FDA-cleared K253969

ADAS 3D

Adas3D Medical S.L.

ADAS 3D supports visualization and analysis of MR and CT images of the heart for individual patients with cardiovascular disease, including patients with myocardial scar from...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart; myocardial scar and cardiac structures
Decision
2026-06-29
Radiotherapy planningCardiac imagingOncology quantification
FDA-cleared K254016

MI View&GO

Siemens Medical Solutions USA, Inc.

MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images across one or more time...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body, organs, tumors, heart, brain, and oncology regions
Decision
2026-02-10
Radiotherapy planningCardiac imagingOncology quantification
FDA-cleared K252634

Imagine® Enterprise Suite

Softlink International Private Limited

Imagine Enterprise Suite receives, stores, shares, visualizes, quantifies, and processes images from multiple modalities; MPXA-2000 supports coronary-angiography calculation with...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Cardiac and coronary anatomy plus multi-modality clinical studies
Decision
2026-01-16
Cardiac imagingQuantification and segmentation
FDA-cleared K250330

3mensio Workstation

Pie Medical Imaging BV

3mensio Workstation is standalone medical-image analysis software for advanced visualization and quantitative analysis of cardiovascular structures. It supports CT, X-ray...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart/Cardiovascular
Decision
2025-11-03
Cardiac imagingQuantification and segmentation