Release and scope verification
Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K240791.
exact submission · checked 2026-09-04FDA-cleared profile
ADAS 3D
Adas3D Medical S.L
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 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
- 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.
- Intended users
- Qualified cardiologists, electrophysiologists, radiologists, and trained technicians.
- Care setting and population
- Cardiology, electrophysiology, and radiology workflows involving cardiovascular MR and CT.
- Workflow role
- Cardiac image post-processing and myocardial-scar assessment for clinical review and EP planning.
- Required input
- DICOM enhanced cardiovascular MR and CT angiography images.
- Output and human action
- Visualizations and quantitative myocardial-fibrosis, cardiac-structure, and procedure-planning results exportable in supported standard formats.
- 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.
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.
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.
- 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.
- Security and privacy
- Not established in reviewed sources
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.
- Monitoring and change control
- Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K240791.
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 2026-09-04Interoperability 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 2026-09-04Clinical acceptance
Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K240791.
exact submission · checked 2026-09-04Economic 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 2026-09-04Lifecycle monitoring
Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.
exact submission · checked 2026-09-04Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- 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.
- Reported sensitivity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
- Reported specificity
- Not applicable
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
FDA 510(k) decision evidence and product verification for the exact submission. · Heart; myocardial scar and cardiovascular structures
exact submission · Tested version: ADAS 3D · Sponsor or vendor studyK240791
FDA-submitted evidence for the exact decision; it is not independent clinical validation and does not establish local production qualification.
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
No public list price or commercial contract for the exact submission and version was identified.
- Reimbursement and coding
- Not established in reviewed sources
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 StatesThis public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.
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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: 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.
- Verify pricing and total cost: No public list price or commercial contract for the exact submission and version was identified.
- Verify reimbursement and coding relevance: No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
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
20Reviewed PubMed leads
6Reviewed 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
Source ledger
Sources accessed through 2026-09-04.
- FDA 510(k) decision material K240791: ADAS 3D U.S. Food and Drug Administration · 2026-09-04
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- Adas 3D model card (K240791) American College of Radiology · 2026-09-01
- 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
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
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
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
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