PIUR tUS inside

K250484

PIUR Imaging GmbH · cleared 2025-06-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“PIUR tUS inside System is a computer-aided detection device intended to assist and support medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules.”

Algorithmcomputer vision and machine learning algorithm

source quote (p.10)

“User-selected computer vision and machine learning algorithm suggested volumes of thyroid lobe and nodules are visualized to be confirmed by user.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.8)

“PIUR tUS inside has been designed to meet cybersecurity requirements using design vulnerability assessments utilizing the Common Vulnerability Scoring System (CVSS), providing open source and 3rd party libraries in the SBOM's and performing gray box penetration testing.”

Validation studies (1)

Bench

sample size not stated

endpoints: accuracy of suggested ROIs; quantification of sonographic characteristics

standards: ISO 13485:2016, ISO 14971:2019, IEC 62366-1:2015, IEC 62304:2015, IEC 82304-1:2016, EN 301 489-1 V2.2.3 (2019-11), EN 301 489-17 V3.2.4:2020, IEC 60601-1:2013, IEC 60601-1-2:2014, IEC 60601-2-37:2016, ISO 15223-1:2021, IEC 60417:2002, NEMA PS 3.1-3.20:2023

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

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).