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EchoNavigator Release 1

by Philips Medical Systems Nederland B.V.

510(k) K121781

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121781↗

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 · Abbreviated NumberK121781 Date26 Oct 2012ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
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 EchoNavigator Release 1 is a medical imaging device classified as an Ultrasound Imaging System with Navigation Assistance Software. It integrates real-time ultrasound imaging with advanced navigation tools to enhance procedural guidance, particularly in interventional radiology and cardiology. Designed to improve spatial orientation during procedures, it aids clinicians in visualising anatomical structures and guiding instruments with greater precision.

This device is supplied as a software module for use with compatible ultrasound systems and is intended for single-use or multi-use depending on the host platform’s configuration. It operates in clinical settings such as operating rooms, catheterisation labs, and radiology suites, where procedural navigation is critical. Authorised under FDA 510(k) clearance (K121781) and MDD compliance, it adheres to regulatory standards for medical imaging software. No specific sterility or MRI safety classifications are noted in the provided data.

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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.

  • What types of clinical procedures does the EchoNavigator Release 1 support, and how does it improve precision during those procedures?

    The EchoNavigator Release 1 is designed to enhance procedural guidance in interventional radiology and cardiology, where spatial orientation is critical. It integrates real-time ultrasound imaging with navigation tools to help clinicians visualize anatomical structures more clearly and guide instruments with greater precision. This is particularly useful in settings like catheterization labs or radiology suites, where accurate instrument placement can significantly impact patient outcomes.

  • Is the EchoNavigator Release 1 a standalone device, or does it require integration with another system?

    The EchoNavigator Release 1 is supplied as a software module and is intended for use with compatible ultrasound systems. It does not function independently but rather enhances existing imaging platforms by adding navigation assistance capabilities. Compatibility depends on the host system’s configuration, which may determine whether it is used for single-use or multi-use scenarios.

  • How is the EchoNavigator Release 1 regulated, and what does its FDA clearance mean for clinicians?

    The EchoNavigator Release 1 holds FDA 510(k) clearance (K121781) under an abbreviated review process, classified as substantially equivalent to a predicate device. This means it has been evaluated and determined to meet regulatory standards for safety and effectiveness as a medical imaging software tool with navigation assistance. Clinicians can rely on this clearance as an indication that the device adheres to U.S. regulatory requirements for its intended use in procedural guidance.

  • Does the EchoNavigator Release 1 require special handling or storage conditions, such as sterility or environmental controls?

    The provided data does not specify any sterility requirements or special environmental controls for the EchoNavigator Release 1, as it is a software module rather than a physical device requiring sterilization. However, since it operates on compatible ultrasound systems, proper handling of the host platform (e.g., cleaning, calibration, and storage) remains essential to ensure optimal performance and clinical safety.