Family package caveats
EHR requires Works Enterprise; worksheets and 1 TB cloud storage require Connect.
product family ยท checked 2026-09-06FDA-cleared profile
AI Platform 2.2 (AIP002)
Exo Imaging
Authorized purpose: Provides AI-assisted cardiac, lung and abdominal quality feedback and measurements; users remain responsible for scan quality and diagnosis and must not rely solely on the software.
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: Provides AI-assisted cardiac, lung and abdominal quality feedback and measurements; users remain responsible for scan quality and diagnosis and must not rely solely on the software.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Provides AI-assisted cardiac, lung and abdominal quality feedback and measurements; users remain responsible for scan quality and diagnosis and must not rely solely on the software.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Heart/Cardiovascular; Lung; Abdomen/Pelvis Input: Single- or multi-frame DICOM ultrasound images from software modules integrated into compatible ultrasound devices.
- Who uses it? Intended users: Healthcare professionals trained and qualified to conduct echocardiography, abdominal, and lung ultrasound scans in the current standard of care while acquiring ultrasound images.
- What does the software produce? Output: Lung A/B-line presence and count; cardiac LVEF, IVC and myocardial-wall measurements; image-quality feedback for cardiac, lung and added abdominal views.
- What is its most important limitation? Key limitation: The added abdominal indication is outside the predicate PCCP; users must use clinical judgment and independently assess diagnostic adequacy.
Clinical takeaway
Clinical role: Provides AI-assisted cardiac, lung and abdominal quality feedback and measurements; users remain responsible for scan quality and diagnosis and must not rely solely on the software.
Evidence takeaway
Evidence from the reviewed source record: The FDA summary reports image-quality agreement in retrospective clip validation and real-time evaluation; no disease-detection sensitivity or specificity is reported.
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
- Provides AI-assisted cardiac, lung and abdominal quality feedback and measurements; users remain responsible for scan quality and diagnosis and must not rely solely on the software.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
- Intended users
- Healthcare professionals trained and qualified to conduct echocardiography, abdominal, and lung ultrasound scans in the current standard of care while acquiring ultrasound images.
The exact indications for use identify the trained and qualified healthcare-professional scope.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Measurement or quantification
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Single- or multi-frame DICOM ultrasound images from software modules integrated into compatible ultrasound devices.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Output and human action
- Lung A/B-line presence and count; cardiac LVEF, IVC and myocardial-wall measurements; image-quality feedback for cardiac, lung and added abdominal views.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Limitations
- The added abdominal indication is outside the predicate PCCP; users must use clinical judgment and independently assess diagnostic adequacy.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
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
- K260217
- Modality
- Ultrasound
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Anatomy
- Heart/Cardiovascular; Lung; Abdomen/Pelvis
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Clearance type
- 510(k)
- Decision date
- 2026-02-24
- 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
- Current Exo Iris specifications describe DICOM worklist/store/send and PACS/VNA connectivity; EHR access requires Exo Works Enterprise, and worksheets/1 TB cloud storage require Connect.
Package requirements are family-level and do not establish that every AIP002 deployment includes them.
- Deployment and data flow
- AI modules and APIs are integrated by the ultrasound-device programmer; current hosting details were not established.
- Security and privacy
- Vendor documentation pending
- Training and support
- Not established in reviewed sources
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
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
- The FDA summary reports image-quality agreement in retrospective clip validation and real-time evaluation; no disease-detection sensitivity or specificity is reported.
- Reported sensitivity
- Not established in reviewed sources
- Reported specificity
- Not established in reviewed sources
Clip-level quality ICC
0.95 ICC
- EndpointAbdominal image-quality agreement
- Population184 patients, 200 clips
- Tested versionAI Platform 2.2
AI Platform 2.2 abdominal quality validation
- DesignRetrospective clip validation with separate real-time usability evaluation.
- Population184 patients / 200 clips in retrospective validation; 186 real-time scans by 12 users in separate evaluation.
- Scopeexact submission
- Tested versionAI Platform 2.2 (AIP002)
- Samplen=184
- IndependenceIndependence not established
K260217
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
- Reimbursement and coding
- Research pending
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
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
- Verify security and privacy controls.
- Verify training.
- Verify pricing and total cost.
- Verify reimbursement and coding relevance.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: 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.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-19Last searched
24Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
No stored literature or trial candidates; empty metadata snapshots were screened. 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, acr ai central product, fda decision summary, vendor technical page, literature index, trial registry, fda decision summary packet, 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
-
FDA K260217: AI Platform 2.2 (AIP002)
Scope: purpose, modality, anatomy, input, output, limitations, evidenceSummary, intendedUsers, clinicalUse
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
AI Platform 2.2 (AIP002) model card (K260217)
Scope: intendedUsers, careSetting, 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
-
Exo Iris technical specifications
Scope: product_family_implementation
-
AI Platform 2.2: K260217 clearance and 510(k) summary
Scope: identity, clinical, implementation, evidence
Research history
-
K260217 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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