AI Platform 2.2 (AIP002)

K260217

Exo Imaging · cleared 2026-02-24 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“Exo AI Platform 2.2 (AIP 2.2) 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.8)

“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 (2)

Retrospective clinical

n=184 patients

endpoints: overall agreement between the Quality AI and quality rated by the experienced sonographers was ICC = 0.94 (.94 – .95) for frames and ICC = 0.95 (.94 – .96) for clips.

standards: IEC 62304:2006/AC:2015, ISO 14971

Prospective clinical

n=186 scans

endpoints: 96.6% of the clips rated as ACEP quality of 3 or above by expert readers, also received at least “Minimum criteria met for diagnosis” image quality by Clip Quality AI.; Additionally, 96.1% of scans that were considered as “Minimal criteria met for diagnosis” or “good” by Quality AI were also deemed diagnostic by experts (ACEP score of 3 or higher).

standards: IEC 62304:2006/AC:2015, ISO 14971

Reported performance (2 observations)

agreement_kappaas written: “Intraclass Correlation Coefficient (ICC) for frames”0.94CI 0.94 - 0.95

source quote (p.9)

“The overall agreement between the Quality AI and quality rated by the experienced sonographers was ICC = 0.94 (.94 – .95) for frames”

agreement_kappaas written: “Intraclass Correlation Coefficient (ICC) for clips”0.95CI 0.94 - 0.96

source quote (p.9)

“and ICC = 0.95 (.94 – .96) for clips.”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).