510(k) · Radiology

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

by Philips Ultrasound, Inc.

EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System is an AI-enabled medical device from Philips Ultrasound, Inc. that the U.S. FDA cleared through 510(k) K201012 on May 1, 2020. 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 2020, all FDA AI clearances in 2020, top radiology AI devices.

Key facts

Submission numberK201012
Pathway510(k)
Date of final decision
Company (FDA list)Philips Ultrasound, Inc.
Lead review panelRadiology
Primary product codeIYN — System, Imaging, Pulsed Doppler, Ultrasonic
Applicant (openFDA)Philips Ultrasound, Inc.
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 Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System went through this pathway (K201012).

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 #10 of 124 under that code. Philips Ultrasound, Inc. has 1 AI-enabled device 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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