Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept or reject measurements.
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
Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept or reject measurements.
FDA source Exact FDA submission Checked 2026-09-05
Multi-frame apical four-chamber cardiac ultrasound images from adults with suspected disease. Validation included routine clinical images from cart-based and portable systems at 1.2-4 MHz.
FDA source Exact FDA submission Checked 2026-09-05
The validation frequency range is not a universal compatibility guarantee.
No built-in viewer; integration into a legally marketed ultrasound imaging device is required. Patient management must not rely solely on Strain AI analysis.
FDA source Exact FDA submission Checked 2026-09-05
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
K242359
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
A software module integrated by another programmer into a legally marketed ultrasound imaging device; it uses that device's user interface rather than a built-in viewer.
FDA source Exact FDA submission Checked 2026-09-05
The earlier baseline's generic DICOM/PACS claim was not substantiated in this summary. Current Exo Iris interoperability is recorded only as product-family context.
Vendor confirmation Exact product version Checked 2026-09-05
No current security attestation or host-specific retention, access and update architecture was established for SAI001.
Training and support
Vendor documentation pending
Vendor confirmation Exact product version Checked 2026-09-05
Host-device onboarding and competency requirements for reviewing or rejecting GLS measurements were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact product version Checked 2026-09-05
No ongoing quality-monitoring service was established. Editorial site questions: test A4C adequacy, rejected measurements and host software updates.
Current Exo Iris interoperability context
The official Iris specifications list DICOM worklist, store and send and PACS/VNA integration. EHR integration requires Exo Works Enterprise; the listed workflow worksheets and 1 TB cloud storage require Exo Works Connect.
product family · checked 2026-09-06
Host-platform package context only; this page does not establish these interfaces for every SAI001 installation.
Reviewed sources checked Exact FDA submission Checked 2026-09-05
GLS agreement is reported; a disease-detection sensitivity with a specified threshold was not established.
Reported specificity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-05
The reviewed summary does not establish disease-detection specificity.
GLS intraclass correlation coefficient
0.95 ICC
Agreement of A4C global longitudinal strain with reference-device measurements in Held-out routine cardiac ultrasound data from multiple sites, ages 21-96, cart-based and portable systems; sample size unreported.
Standalone measurement-agreement testing on clinical images separated from training, with reference-device ground truth. · Routine cardiac examinations from multiple sites and scanner types; reported age range 21-96.
exact submission · Tested version: Strain AI (SAI001), K242359 · Independence not established
K242359
Us2.v2 is the reference device; ICC and RMSD assess measurement agreement, not disease-detection accuracy. No exact SAI001 publication was established by stored candidate titles.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Research pending
Needs research Exact product version Checked 2026-09-05
A priced SAI001 license or public procurement contract was not reviewed; an Exo Iris bundle price would not establish this module's price.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-05
No applicable payer policy content was reviewed for this software or strain service.
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
Reviewed sources checked Exact FDA submission Checked 2026-09-04
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: No current security attestation or host-specific retention, access and update architecture was established for SAI001.
Verify training: Host-device onboarding and competency requirements for reviewing or rejecting GLS measurements were not established.
Verify pricing and total cost: A priced SAI001 license or public procurement contract was not reviewed; an Exo Iris bundle price would not establish this module's price.
Verify reimbursement and coding relevance: No applicable payer policy content was reviewed for this software or strain service.
Verify local validation and lifecycle monitoring: No ongoing quality-monitoring service was established. Editorial site questions: test A4C adequacy, rejected measurements and host software updates.
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.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-06Last searched
18Fields reviewed
9Source classes checked
14Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
All 14 stored titles screened and excluded as exact-product evidence: 40055942 is a computer vision syndrome review; the other 13 concern microbiology, microbial strains or veterinary virology. None establishes Exo SAI001 cardiac GLS. No trials were stored. The current discovery snapshot contains 14 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, vendor technical page, literature index, trial registry, pubmed, clinical trials, openfda device recall
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