ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for AI Platform 2.0 (AIP002); FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission ยท checked 2026-09-08FDA-cleared profile
AI Platform 2.0 (AIP002)
Exo Imaging
Authorized purpose: Non-invasive processing of adult ultrasound for cardiac measurements including LVEF, wall thickness, and IVC diameter, plus lung and cardiac image-quality feedback in patients with suspected disease.
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: Non-invasive processing of adult ultrasound for cardiac measurements including LVEF, wall thickness, and IVC diameter, plus lung and cardiac image-quality feedback in patients with suspected disease.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Non-invasive processing of adult ultrasound for cardiac measurements including LVEF, wall thickness, and IVC diameter, plus lung and cardiac image-quality feedback in patients with suspected disease.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Heart and lungs Input: Single- and multi-frame DICOM ultrasound images from scanners within the specified compatibility range, including apical four-chamber and parasternal long-axis cardiac views and lung scans.
- Who uses it? Intended users: Qualified healthcare professionals trained to conduct echocardiography and lung ultrasound scans; certified healthcare professionals interpret the data and remain responsible for scan quality and diagnosis.
- What does the software produce? Output: Lung A-line and B-line presence or count and per-frame or per-clip quality scores; cardiac LVEF, interventricular-septum and posterior-wall thickness from the PLAX view, IVC minimum diameter on inspiration, IVC maximum diameter on expiration, and cardiac quality scores.
- What is its most important limitation? Key limitation: The device is for adults and patient-management decisions must not rely solely on its analysis. Certified healthcare professionals must review the data and ensure scan quality and diagnostic appropriateness. The packet establishes module-specific validation, not a single performance result for every possible ultrasound use.
Clinical takeaway
Clinical role: Non-invasive processing of adult ultrasound for cardiac measurements including LVEF, wall thickness, and IVC diameter, plus lung and cardiac image-quality feedback in patients with suspected disease.
Evidence takeaway
Evidence from the reviewed source record: FDA validation evaluated left-ventricular wall thickness and IVC measurements in 100 subjects each against the average of three experts: ICC 0.93 for IVSd (95% CI 0.89-0.96), 0.94 for PWd (0.89-0.97), 0.93 for IVC minimum diameter (0.90-0.95), and 0.94 for IVC maximum diameter (0.90-0.96). Quality AI used 184 patients, 226 clips, and 29,732 frames, with ICC 0.94 for frames (95% CI 0.94-0.95) and clips (0.92-0.95). In real-time testing, 396 scans were performed by 26 users, including 18 novices with two hours of training; 98.3% and 98.0% were conditional agreement proportions against expert quality ratings.
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
- Non-invasive processing of adult ultrasound for cardiac measurements including LVEF, wall thickness, and IVC diameter, plus lung and cardiac image-quality feedback in patients with suspected disease.
- Intended users
- Qualified healthcare professionals trained to conduct echocardiography and lung ultrasound scans; certified healthcare professionals interpret the data and remain responsible for scan quality and diagnosis.
- Care setting and population
- Adult echocardiography and lung-ultrasound workflow, including point-of-care scanning described in the FDA validation data.
- Workflow role
- Real-time acquisition-quality feedback and measurement support; the algorithm/API modules are intended as accessories integrated by a programmer into a legally marketed ultrasound imaging device, while clinicians remain responsible for interpretation and management.
- Required input
- Single- and multi-frame DICOM ultrasound images from scanners within the specified compatibility range, including apical four-chamber and parasternal long-axis cardiac views and lung scans.
- Output and human action
- Lung A-line and B-line presence or count and per-frame or per-clip quality scores; cardiac LVEF, interventricular-septum and posterior-wall thickness from the PLAX view, IVC minimum diameter on inspiration, IVC maximum diameter on expiration, and cardiac quality scores.
- Limitations
- The device is for adults and patient-management decisions must not rely solely on its analysis. Certified healthcare professionals must review the data and ensure scan quality and diagnostic appropriateness. The packet establishes module-specific validation, not a single performance result for every possible ultrasound use.
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
- Accepts DICOM data from ultrasound scanners in the specified range; the AI algorithm and API modules are intended to be integrated by another programmer into a legally marketed ultrasound imaging device. Exact local interfaces and versions are not established.
- Deployment and data flow
- Vendor documentation pending
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
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.
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 validation evaluated left-ventricular wall thickness and IVC measurements in 100 subjects each against the average of three experts: ICC 0.93 for IVSd (95% CI 0.89-0.96), 0.94 for PWd (0.89-0.97), 0.93 for IVC minimum diameter (0.90-0.95), and 0.94 for IVC maximum diameter (0.90-0.96). Quality AI used 184 patients, 226 clips, and 29,732 frames, with ICC 0.94 for frames (95% CI 0.94-0.95) and clips (0.92-0.95). In real-time testing, 396 scans were performed by 26 users, including 18 novices with two hours of training; 98.3% and 98.0% were conditional agreement proportions against expert quality ratings.
- 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.
AI Platform 2.0 (AIP002) regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K240953
- Samplen=184
- IndependenceIndependence not established
K240953
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 K240953 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 K240953. 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 deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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 K240953 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
21Fields 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
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FDA K240953: AI Platform 2.0 (AIP002)
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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AI Platform 2.0 (AIP002) model card (K240953)
Scope: intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
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openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
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openFDA exact recall query for K240953
Scope: postmarketSafety
Research history
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K240953 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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