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.5)
“The Infinity software runs on a stand-alone computer (Infinity Workstation – not part of the medical product) that fulfils the defined minimum requirements. It takes as an input a sequence of ultrasound images that are transmitted from the ultrasound to the Infinity Workstation wirelessly through the Infinity Box. The Infinity Box is a piece of hardware that connects to compatible standard ultrasound systems via digital video output such as HDMI or DVI. It grabs 2D ultrasound images through a video grabber and transfers the images to the Infinity Workstation via Wi-Fi in real-time. In addition, a small Infinity Sensor must be clipped onto the ultrasound transducer using individually designed attachments. An inertial measurement unit (IMU) tracks the orientation of the transducer during the scan and sends this information to the Infinity Workstation via Bluetooth. The Infinity Workstation combines information from the Infinity Box and Sensor to generate tomographic 3D ultrasound volumes on which the above-described image analysis can be performed.”
Algorithmcomputer vision, machine learning, pattern recognition and quantification method
source quote (p.10)
“Based on computer vision, machine learning, pattern recognition and quantification method.”
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, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, September 2023, Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions, September 2022

Retrospective clinical

n=196 patients

endpoints: non-inferiority of the PIUR tUS Infinity in ACR TI-RADS classification against conventional 2D ultrasound using 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)

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, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, September 2023, Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions, September 2022

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K240036