AI Platform 2.0 (AIP002)
K240953Exo Imaging · cleared 2024-08-05 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.8)
“Deep Convolutional Neural Networks for Segmentation, Landmark Detection and Classification”
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”
source quote (p.10)
“A Predetermined Change Control Plan (PCCP) is included with AI Platform 2.0. The PCCP specifies anticipated software modifications, implementation methods and validation criteria that will be used to implement the software modifications in a controlled manner and ensure the subject device remains as safe and effective as the predicate.”
Validation studies (3)
Retrospective clinical
n=100 patients
endpoints: Inter class correlation (ICC)
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”
Reader study (MRMC)
n=184 patients
endpoints: Inter class correlation (ICC)
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”
Reader study (MRMC)
n=396 scans
endpoints: Percentage of clips/scans meeting quality criteria as rated by experts
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 (6 observations)
source quote (p.10)
“InterVentricular Septum (IVSd) 0.93 (0.89 - 0.96)”
source quote (p.10)
“Posterior Wall (PWd) 0.94 (0.89 - 0.97)”
source quote (p.10)
“IVC Dmin 0.93 (0.90 - 0.95)”
source quote (p.10)
“IVC Dmax 0.94 (0.90 - 0.96)”
source quote (p.10)
“The overall agreement between the Quality AI and quality rated by the experienced sonographers was ICC = 0.94 (95% CI .94 – .95) for frames”
source quote (p.10)
“and ICC = 0.94 (95% CI .92 – .95) 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
- 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). 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).