Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
inHEART Models
inHEART, SAS
Authorized purpose: Create, review, analyze, annotate, export, and use 3D cardiac models to support reading, reporting, and therapeutic-intervention planning.
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: Create, review, analyze, annotate, export, and use 3D cardiac models to support reading, reporting, and therapeutic-intervention planning.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Create, review, analyze, annotate, export, and use 3D cardiac models to support reading, reporting, and therapeutic-intervention planning.
- Which images or clinical context are in scope? Modality: CT/CTA; MRI Anatomy or clinical context: Cardiac structures, including the aorta, atria, ventricles, pulmonary artery trunk, and right atrium/inferior vena cava structures described in the FDA performance table Input: DICOM-compliant pre-operative CT and MR images for the suite; inHEART Models AI specifically preprocesses CT images and is indicated for adults only.
- Who uses it? Intended users: Qualified medical professionals, including physicians, cardiologists, radiologists, and technicians; final patient-management decisions remain with the users.
- What does the software produce? Output: Automatic initial 3D segmentation/modeling from the AI module, followed by 3D cardiac models that can be displayed, reviewed, analyzed, annotated, exported, reported, and used for therapeutic planning. The packet describes 2D/3D viewers, quantitative analysis, and manual/semi-automated review and editing.
- What is its most important limitation? Key limitation: The AI module is adult and CT-only. The product is not intended for use with or primary diagnostic interpretation of mammography images. The FDA performance criteria expressly describe the AI module as an initialization step that does not replace manual expert segmentation; users review and edit outputs in the cleared suite.
Clinical takeaway
Clinical role: Create, review, analyze, annotate, export, and use 3D cardiac models to support reading, reporting, and therapeutic-intervention planning.
Evidence takeaway
Evidence from the reviewed source record: FDA packet: 100 independent CT cases selected from 2023; two external experts established the ground truth. Performance was calculated on revised expert segmentations based on AI initialization versus ground truth/predicate outputs, rather than on unreviewed AI output alone. Average Dice was 0.94, average ASSD 1.17 mm, and average volume variation 9.18 mL/7%.
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
- Create, review, analyze, annotate, export, and use 3D cardiac models to support reading, reporting, and therapeutic-intervention planning.
- Intended users
- Qualified medical professionals, including physicians, cardiologists, radiologists, and technicians; final patient-management decisions remain with the users.
- Care setting and population
- Pre-operative cardiac imaging and treatment-planning workflow; the specific facility type is not established in the FDA packet.
- Workflow role
- AI-assisted initial 3D segmentation/modeling followed by review, editing, visualization, reporting, and treatment-planning support.
- Required input
- DICOM-compliant pre-operative CT and MR images for the suite; inHEART Models AI specifically preprocesses CT images and is indicated for adults only.
- Output and human action
- Automatic initial 3D segmentation/modeling from the AI module, followed by 3D cardiac models that can be displayed, reviewed, analyzed, annotated, exported, reported, and used for therapeutic planning. The packet describes 2D/3D viewers, quantitative analysis, and manual/semi-automated review and editing.
- Limitations
- The AI module is adult and CT-only. The product is not intended for use with or primary diagnostic interpretation of mammography images. The FDA performance criteria expressly describe the AI module as an initialization step that does not replace manual expert segmentation; users review and edit outputs in the cleared suite.
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
- K231683
- Modality
- CT/CTA; MRI
- Anatomy
- Cardiac structures, including the aorta, atria, ventricles, pulmonary artery trunk, and right atrium/inferior vena cava structures described in the FDA performance table
- Clearance type
- 510(k)
- Decision date
- 2024-02-29
- 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
- Standalone and web-based software suite. The packet specifies DICOM-compliant input, a macOS imaging-processing module, a Windows/macOS web platform with supported browsers, and a standard internet connection for the web platform; exact local interface versions and deployment topology are not established.
- Deployment and data flow
- On-cloud
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for inHEART Models; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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 packet: 100 independent CT cases selected from 2023; two external experts established the ground truth. Performance was calculated on revised expert segmentations based on AI initialization versus ground truth/predicate outputs, rather than on unreviewed AI output alone. Average Dice was 0.94, average ASSD 1.17 mm, and average volume variation 9.18 mL/7%.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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.
inHEART Models regulatory performance study summary
- DesignStand-Alone Performance
- PopulationPopulation described in the exact-submission ACR model card
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K231683
- Samplen=100
- IndependenceIndependence not established
K231683
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K231683 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K231683. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K231683 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
2Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 2 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 2 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
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FDA K231683: inHEART Models
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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inHEART Models model card (K231683)
Scope: intendedUsers, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K231683
Scope: postmarketSafety
Research history
-
K231683 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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