EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System

Philips Ultrasound, Inc. · System, Imaging, Pulsed Doppler, Ultrasonic

What it does

Supports the imaging workflow around multi-modality studies — routing, scheduling, or image management — rather than interpreting the images.

Who it's for

Imaging departments and informatics teams managing study flow.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)

Submission #K201012

Product codeIYN

Decision dateMay 1, 2020

PanelRadiology

FDA recordaccessdata

EU (CE)

Statusunknown

Risk class—

Notified body—

EMDN code—

Basic UDI-DI—

AI Act class—

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

CompanyPhilips Ultrasound, Inc.

Foundedunknown

Cite this page

RadPigeon. "EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System (Philips Ultrasound, Inc.)." AI Devices registry. https://radpigeon.news/ai/device/epiq-diagnostic-ultrasound-system-series-affiniti-diagnostic-ultrasound-system-s

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.