Skip to content

HeartNavigator Release 1

by Philips Medical Systems Nederland B.V.

510(k) K111245

Active European Union and United States

CE MDR 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) K111245↗

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 NumberK111245 Date29 Jul 2011ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
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  • Withdrawn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/MDR, 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.

HeartNavigator Release 1 is a medical imaging software device classified under radiology, designed for automated segmentation and analysis of cardiac structures from computed tomography (CT) scans. It provides precise anatomical measurements and visualisation of the heart, including the mitral valve, left atrial appendage, and aortic root, to support procedural planning for interventions such as mitral valve replacement and left atrial appendage closure.

This software is supplied as a standalone application for use in radiology or cardiac catheterisation laboratories, requiring integration with a compatible CT imaging system. It is intended for single-use per CT dataset and does not require sterilisation. The device holds FDA 510(k) clearance under the product code LLZ, with additional authorisations under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). No MRI safety classification or reusable components are specified.

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

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 specific parts of the heart does HeartNavigator Release 1 analyze, and how might this help in planning procedures?

    HeartNavigator Release 1 focuses on automated segmentation and measurement of critical cardiac structures visible on CT scans, including the mitral valve, left atrial appendage, and aortic root. These detailed anatomical visualizations assist clinicians in procedural planning for interventions like mitral valve replacement or left atrial appendage closure by providing precise spatial data to improve accuracy and safety.

  • Is HeartNavigator Release 1 designed for repeated use on the same patient, or is it intended for a single CT dataset?

    HeartNavigator Release 1 is intended for single-use per CT dataset. Since it processes and analyzes a specific scan, it does not require sterilization or reuse on the same patient, aligning with its software-based design for one-time analysis of imaging data.

  • How is HeartNavigator Release 1 supplied, and what kind of integration does it require with existing systems?

    HeartNavigator Release 1 is supplied as a standalone software application, but it requires integration with a compatible CT imaging system to function. This means it is not a plug-and-play device but must be configured to work alongside the radiology or cardiac catheterization lab’s existing CT equipment for accurate segmentation and analysis.

  • What regulatory pathways has HeartNavigator Release 1 followed, and which committees or directives are involved?

    HeartNavigator Release 1 has undergone regulatory review through the FDA’s 510(k) pathway, receiving clearance under product code LLZ with a decision classified as substantially equivalent. It also holds authorizations under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), reflecting compliance with both European and U.S. regulatory standards for imaging software.