510(k) · Radiology

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

by Philips Ultrasound, LLC

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems is an AI-enabled medical device from Philips Ultrasound, LLC that the U.S. FDA cleared through 510(k) K260680 on May 27, 2026. Its lead review panel is Radiology and its primary product code is IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

See also FDA-cleared AI radiology devices in 2026, all FDA AI clearances in 2026, top radiology AI devices.

Key facts

Submission numberK260680
Pathway510(k)
Date of final decision
Company (FDA list)Philips Ultrasound, LLC
Lead review panelRadiology
Primary product codeIYN — System, Imaging, Pulsed Doppler, Ultrasonic
Applicant (openFDA)Philips Ultrasound, LLC
Applicant locationBothell, WA, US
Device classClass 2
Regulation number21 CFR 892.1550
Decision codeSESE
Submission typeSpecial

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems went through this pathway (K260680).

openFDA lists it as a Class 2 device under 21 CFR 892.1550. Class II devices are moderate risk and are subject to general and special controls.

Product code IYN covers 124 devices on the FDA AI list. By decision date, this device is #122 of 124 under that code. Philips Ultrasound, LLC has 21 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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