AI Platform 2.0 (AIP002)

K240953

Exo Imaging · cleared 2024-08-05 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Exo AI Platform 2.0 (AIP 2.0) is a software as a medical device (SaMD) that helps qualified users with image-based assessment of ultrasound examinations in adult patients.”
AlgorithmDeep Convolutional Neural Networks for Segmentation, Landmark Detection and Classification
source quote (p.8)
“Deep Convolutional Neural Networks for Segmentation, Landmark Detection and Classification”
Adaptive (vs locked)No
source quote (p.7)
“Ultrasound image processing software implementing artificial intelligence, including non-adaptive machine learning algorithms trained with clinical data intended for non-invasive analysis of ultrasound data”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=100 patients

endpoints: Inter class correlation (ICC) between the AI and the ground truth

standards: IEC 62304:2006/AC:2015 Medical device software Software life cycle processes, FDA's 'Content of Premarket Submissions for Device Software Functions" Guidance for Industry and Food and Drug Administration Staff Document issued on June 14, 2023, FDA Guidance (June 2022) “Technical performance assessment of quantitative imaging in radiological device premarket submissions”

Reported performance (4 observations)

agreement_kappaas written: “ICC for InterVentricular Septum (IVSd)”0.93CI 0.89 – 0.96
source quote (p.10)
“Table 1: Summary of AI Platform performance for left ventricle wall thickness and IVC measurement”
agreement_kappaas written: “ICC for Posterior Wall (PWd)”0.94CI 0.89 – 0.97
source quote (p.10)
“Table 1: Summary of AI Platform performance for left ventricle wall thickness and IVC measurement”
agreement_kappaas written: “ICC for IVC Dmin”0.93CI 0.90 – 0.95
source quote (p.10)
“Table 1: Summary of AI Platform performance for left ventricle wall thickness and IVC measurement”
agreement_kappaas written: “ICC for IVC Dmax”0.94CI 0.90 – 0.96
source quote (p.10)
“Table 1: Summary of AI Platform performance for left ventricle wall thickness and IVC measurement”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K260217 (decision 2026-02-24) from Exo Imaging for a matching device line ("AI Platform 2.2 (AIP002)") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.

    first seen 2026-07-08 · k_number:K260217

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K240953