Ultrasound Workspace (UWS 6.0)
K241659Philips Ultrasound LLC · cleared 2025-02-10 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The semi-automated Segmental Wall Motion feature (SWM) evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. It performs border detection and tracking to identify each of the LV segments, provides segmental wall motion scores for each segments of the LV by using machine learning algorithms and calculates an overall wall motion score index (WMSI) as the average of the segmental scores. Ultrasound Workspace is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.”
source quote (p.5)
“The semi-automated Segmental Wall Motion feature (SWM) evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. It performs border detection and tracking to identify each of the LV segments, provides segmental wall motion scores for each segments of the LV by using machine learning algorithms and calculates an overall wall motion score index (WMSI) as the average of the segmental scores. 3D Auto TV software enables semi-automated quantification of the tricuspid valve. At a high level, this is accomplished through automatically derived measurements from a segmented model of the tricuspid valve annulus formed by the software through model-based segmentation of the acquired ultrasound images. The 3D Auto CFQ is a new artificial intelligence software which will be introduced on the Ultrasound Workspace Software system starting with Version 6.0. The application provides semi-automated quantification of Mitral Regurgitation (MR) volume and peak flow rate based on 3D color flow images acquired during transesophageal echocardiography (TEE) examinations.”
source quote (p.9)
“Per FDA Guidance Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions, the SWM software is a semi-automated quantitative imaging algorithm, as users are generally expected to review and concur with the initialization and generated results.”
source quote (p.19)
“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2023)”
Validation studies (4)
Retrospective clinical
sample size not stated
endpoints: Lower Confidence Bound for the Pearson's correlation coefficient to be >0.8 for each endpoint.
Reader study (MRMC)
n=3 other
endpoints: Confidence intervals for the limits of agreement were within the acceptance criteria ± 46% and ± 52% for annulus size and annulus shape, respectively, within TEE and TTE arms.; Bias was also evaluated for automation performance, where relative bias based on inter-observer variability was met, specifically within +/- 17.37% for distance (size) and +/- 23.68% for circumference (shape).
Bench
sample size not stated
endpoints: Mean relative error of the measurement primitives on the in-silico phantoms were within +/- 1%, with limits of agreement within acceptance criteria of +/- 5%.
Retrospective clinical
sample size not stated
endpoints: maximum allowable difference (Δ) of 61.6 ml.; mean difference (bias) within +/- 19.2ml; the upper and lower bounds of the 95% confidence interval for Pearson's correlation exceeded the acceptance criteria of > 0.8 when compared to 2D PISA.
Reported performance (1 observation)
source quote (p.20)
“Mean relative error of the measurement primitives on the in-silico phantoms were within +/- 1%, with limits of agreement within acceptance criteria of +/- 5%.”
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).