PIUR tUS Infinity

K240036

PIUR Imaging GmbH · cleared 2024-09-20 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“Operates in combination with hardware to generate 3D volumes. The Infinity Sensor is connected to the ultrasound transducer to detect probe movement for spatial 3D information.”

AlgorithmComputer vision and machine learning algorithms

source quote (p.5)

“Computer vision and machine learning algorithms are applied to a sequence of ultrasound images of the thyroid that have been acquired by a compatible FDA-cleared ultrasound system.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.7)

“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, September 2023”

Validation studies (2)

Bench

sample size not stated

endpoints: Standardized (%) absolute inter-observer differences; Lin's Concordance Correlation Coefficient; Mean Squared Error

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 3.1-3.20:2016

Retrospective clinical

n=196 patients

endpoints: Weighted Cohen's Kappa coefficient; Weighted Cohen's Kappa Coefficients and Limits of Agreement for ultrasound categories (total score, composition, echogenicity, shape, margin and echogenic foci)

Reported performance (3 observations)

agreement_kappaas written: “Standardized (%) absolute inter-observer differences”stated without value

source quote (p.8)

“Standardized (%) absolute inter-observer differences”

agreement_kappaas written: “Weighted Cohen's Kappa coefficient”stated without value

source quote (p.8)

“Weighted Cohen's Kappa coefficient”

agreement_kappaas written: “Weighted Cohen's Kappa Coefficients and Limits of Agreement for ultrasound categories (total score, composition, echogenicity, shape, margin and echogenic foci)”stated without value

source quote (p.8)

“Weighted Cohen's Kappa Coefficients and Limits of Agreement for ultrasound categories (total score, composition, echogenicity, shape, margin and echogenic foci)”

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).