EchoGo Core
K191171Ultromics Ltd · cleared 2019-11-13 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“EchoGo Core is a standalone software application that automatically measures standard cardiac parameters including Ejection Fraction (EF), Global Longitudinal Strain (GLS), and Left Ventricular (LV) volume. EchoGo Core provides a service to calculate those values and provide a report back to the clinician.”
source quote (p.6)
“EchoGo Core uses machine learning-based algorithms.”
source quote (p.6)
“EchoGo Core does not allow for manual editing of contours whereas the predicate, TomTec allows for manual editing.”
source quote (p.7)
“A Cybersecurity and data security testing were conducted to verify that data and patient protected health information security measures are included in the design of the software.”
Validation studies (1)
Retrospective clinical
n=378 patients
endpoints: Root mean square error; ejection fraction; global longitudinal strain; end-diastolic volumes; end-systolic volumes
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K213275 (decision 2021-12-20) from Ultromics Limited for a matching device line ("EchoGo Core (2.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K213275
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).