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. · K201012 · 2020-05-01

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., listed by FDA (510(k), K201012) with a decision date of 2020-05-01. Review panel: Radiology.

FDA submission numberK201012
Pathway510(k)
CompanyPhilips Ultrasound, Inc.
Review panel (specialty)Radiology
FDA decision date2020-05-01
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)14
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.