UltraSight Guidance
K251416Ultrasight , Ltd. · cleared 2025-12-17 · product code QJU · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“UltraSight Guidance is a software application based on machine learning that uses artificial intelligence (AI) to provide dynamic real-time guidance on the position and orientation of the transducer to help non-expert users acquire diagnostic-quality tomographic views of the heart.”
source quote (p.5)
“UltraSight Guidance is a software application based on machine learning that uses artificial intelligence (AI) to provide dynamic real-time guidance on the position and orientation of the transducer to help non-expert users acquire diagnostic-quality tomographic views of the heart.”
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
source quote (p.10)
“The device underwent comprehensive software validation and cybersecurity testing in accordance with the FDA's Guidance "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".”
Validation studies (2)
Retrospective clinical
n=134 patients
endpoints: classification performance between “diagnosable” and “non diagnosable" clips of each view
standards: ACEP guidelines (Rachel B. Liu et al., “Emergency Ultrasound Standard Reporting Guidelines”, 2018, American College of Emergency Physicians)
Retrospective clinical
n=134 patients
endpoints: frame level accuracy of each guidance cue prediction
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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
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).