EchoGo Core (2.0)
K213275Ultromics Limited · cleared 2021-12-20 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“EchoGo Core 2.0 is a software application manufactured by Ultromics to provide a report of left ventricular cardiac function, in the form of secondary capture DICOM files and/or as a structured DICOM report, to aid interpreting physicians with diagnostic decision-making process.”
source quote (p.5)
“EchoGo Core 2.0 utilizes artificial intelligence (AI) for the operator-assisted automatic quantification of commonly measured echocardiographic metrics¹.”
source quote (p.8)
“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=214 cases
endpoints: Root Mean Square Error for LV length; Root Mean Square Error for volume at end diastole (ED) and end systole (ES); Root Mean Square Error for ejection fraction (EF); Root Mean Square Error for stroke volume; Root Mean Square Error for global longitudinal strain (GLS); Root Mean Square Error for segmental longitudinal strain (SLS)
standards: ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices, IEC 62304:2015 – Medical Device Software – Software Life Cycle Processes, IEC 62366-1:2020 – Medical Devices – Application of Usability Engineering to Medical Devices, NEMA PS 3.1 – PS 3.20 (2016) – Digital Imaging and Communications in Medicine (DICOM) Set, IEC ISO 10918-1:1994 – Digital Compression and Coding of Continuous-tone Still Images
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).