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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.

510(k) K201012

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201012↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK201012 Date1 May 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

5 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2354-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2392-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2374-2025 FDA Class III initiated 3 Jul 2025

    To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

  • 2 recalls, same reason

    • Terminated Z-0070-2022 FDA Class II initiated 19 Aug 2021
    • Terminated Z-0071-2022 FDA Class II initiated 19 Aug 2021

    Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EPIQ, Affiniti, CX50, Sparq, and Lumify Diagnostic Ultrasound Systems are portable and fixed diagnostic ultrasound devices designed for high-resolution imaging and Doppler flow analysis. These systems generate and process ultrasound waves using piezoelectric transducers to create real-time visual representations of internal body structures, enabling assessment of organs, tissues, and blood flow for diagnostic purposes.

These systems are reusable capital equipment intended for use in clinical, hospital, and point-of-care settings by trained operators. They are supplied as complete imaging platforms with console-based processing and are regulated under FDA 510(k) clearance (K201012) and EU MDR compliance. No specific sterility or single-use designation is indicated; systems are designed for repeated use in controlled environments.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these ultrasound systems designed for single-use or repeated use in clinical settings? Why does this matter?

    These systems are not single-use; they are reusable capital equipment intended for repeated use in controlled environments like hospitals, clinics, or point-of-care settings. This matters because reusable systems require proper cleaning, disinfection, and maintenance protocols to ensure safety and reliability over time, reducing ongoing costs compared to disposable alternatives.

  • What types of imaging capabilities do these ultrasound systems provide, and how might that benefit a healthcare facility?

    These systems offer high-resolution imaging and Doppler flow analysis, allowing real-time visualization of internal structures, organs, tissues, and blood flow. This is particularly useful for diagnostic assessments in radiology, cardiology, obstetrics, and emergency care, enabling accurate evaluations without radiation exposure or invasive procedures.

  • How are these devices supplied, and what does that mean for setup and maintenance?

    They are supplied as complete imaging platforms with console-based processing, meaning they come pre-assembled with all necessary hardware and software. This simplifies setup—no additional components are required—but facilities must allocate space for the console and ensure proper electrical and environmental conditions (e.g., temperature, humidity) for optimal performance and longevity.

  • Are these systems portable, and if so, how does that affect their use cases?

    Yes, several models in this series (e.g., Sparq and Lumify) are portable, allowing them to be moved between locations within a facility or even to bedside/point-of-care settings. This flexibility is ideal for emergency departments, intensive care units, or remote clinics where mobility and quick access to imaging are critical, reducing patient transport needs.

  • What regulatory pathways have these devices undergone, and what does that imply for purchasing decisions?

    These systems are FDA 510(k)-cleared (under clearance type *Special* and reviewed by the Radiology Advisory Committee) and comply with EU MDR. The FDA clearance (K201012) indicates they meet U.S. safety and effectiveness standards for diagnostic ultrasound devices, while MDR compliance ensures alignment with European regulations. Buyers should verify local regulatory requirements, but these clearances demonstrate rigorous validation for clinical use.