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EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

by Philips Ultrasound LLC 2 variants

510(k) K233788

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233788↗

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 · Traditional NumberK233788 Date13 Feb 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2409-2025 FDA Class III initiated 3 Jul 2025

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

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  • Withdrawn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
FDA applicant
Philips Ultrasound, LLC
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 Series and Affiniti Series Diagnostic Ultrasound Systems are advanced diagnostic imaging devices classified as ultrasound systems. They generate real-time visual images of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes.

These systems are supplied as reusable medical devices and are intended for use in clinical settings such as hospitals, diagnostic imaging centers, and outpatient facilities. They are not single-use and require proper maintenance, calibration, and storage as per manufacturer guidelines. The devices are authorized under FDA 510K clearance and comply with MDR regulations, ensuring adherence to safety and performance standards for diagnostic ultrasound applications.

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