Skip to content

EPIQ 5 Diagnostic Ultrasound System - Affiniti 70 Diagnostic Ultrasound System

by Philips Ultrasound, Inc.

510(k) K163120

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

28 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163120↗

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 NumberK163120 Date10 Jan 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

28 recalls · 28 ongoing · FDA

  • 21 recalls, same reason

    • Ongoing Z-1622-2026 FDA Class III initiated 5 Sep 2025 on shared 510(k) K163120
    • Ongoing Z-1628-2026 FDA Class III initiated 5 Sep 2025 on shared 510(k) K163120
    • Ongoing Z-2411-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2367-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2402-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2408-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2347-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2393-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2351-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2364-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2385-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2413-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2395-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2380-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2350-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2355-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2389-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2360-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2349-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2405-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2410-2025 FDA Class III initiated 3 Jul 2025

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

  • 7 recalls, same reason

    • Ongoing Z-2060-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K163120
    • Ongoing Z-2065-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K163120
    • Ongoing Z-2064-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K163120
    • Ongoing Z-2055-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K163120
    • Ongoing Z-2048-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K163120
    • Ongoing Z-2063-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K163120
    • Ongoing Z-2067-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K163120

    Ultrasound transducer devices were refurbished beyond their useful life.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
Models / Variants
Affiniti 70 Diagnostic Ultrasound System
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 and Affiniti series are diagnostic ultrasound systems designed for real-time imaging of internal body structures using high-frequency sound waves. These systems provide cross-sectional visualisation for assessing organs, tissues, and blood flow, supporting applications in obstetrics, cardiology, abdominal, vascular, and musculoskeletal imaging.

These systems are supplied as reusable medical devices, intended for use in clinical settings such as hospitals, diagnostic centres, and private practices. They are regulated under FDA 510(k) clearance and EU MDR, with the EPIQ and Affiniti models offering varying levels of imaging complexity to accommodate different clinical demands. No specific sterility or single-use requirements are noted; compatibility with MRI environments is not addressed in the provided data.

Other devices from Philips Ultrasound LLC

See all devices from Philips Ultrasound LLC →

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.

  • What clinical applications are these ultrasound systems primarily used for?

    The EPIQ and Affiniti series are designed for real-time imaging across multiple specialties, including obstetrics (e.g., fetal monitoring), cardiology (heart structure and function), abdominal (organ assessment), vascular (blood flow evaluation), and musculoskeletal (tissue and joint evaluation). Their cross-sectional imaging capabilities support diagnostic workflows in hospitals, clinics, and private practices.

  • Are these ultrasound systems single-use or reusable, and what does that mean for maintenance?

    These systems are reusable medical devices, meaning they are built for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. Unlike single-use devices, they require adherence to manufacturer guidelines for servicing, calibration, and software updates to ensure performance and compliance with regulatory standards like FDA 510(k) and EU MDR.

  • How do the EPIQ and Affiniti models differ in terms of intended clinical complexity?

    The EPIQ series (models 5 and 7) and Affiniti series (models 50 and 70) are differentiated by their imaging capabilities and technical specifications, catering to varying clinical demands. For example, the EPIQ 7 and Affiniti 70 likely offer advanced features for complex cases (e.g., cardiology or vascular), while the EPIQ 5 and Affiniti 50 may prioritize accessibility or streamlined workflows for general diagnostic imaging. The exact differences are detailed in the manufacturer’s specifications.

  • What regulatory pathways have these ultrasound systems undergone, and what does that imply for buyers?

    These systems have been cleared via FDA 510(k) (traditional pathway, reviewed by the Radiology Advisory Committee) and comply with EU MDR. This implies they meet U.S. and European safety/effectiveness standards for diagnostic ultrasound devices, though buyers should verify specific model approvals (e.g., K163120 for the FDA) and ensure compatibility with local regulations before purchase or deployment.

  • How are these systems typically supplied, and what should buyers consider for storage or transport?

    The systems are supplied as reusable, integrated ultrasound machines—not as consumables or probes—intended for permanent installation in clinical environments. Buyers should allocate space for proper ventilation, electrical requirements, and access for maintenance. Since they are not sterile or single-use, storage focuses on protecting against physical damage, dust, and environmental factors (e.g., temperature/humidity) to preserve functionality and longevity.