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EK12 Algorithm

by GE Medical Systems Information Technologies, Inc.

510(k) K170155

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

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) K170155↗

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 NumberK170155 Date6 Jun 2017ClearedStatusActive
European UnionCE/MDR 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  • Withdrawn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 Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
MHX
Device class
Class II
Regulation
21 CFR Part 870.1025
Advisory committee
Cardiovascular
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 EK12 Algorithm is a software-based component of physiological patient monitors designed for arrhythmia detection and alarm generation. It functions as an analytical tool embedded within cardiac monitoring systems to identify and alert clinicians to abnormal heart rhythms, supporting timely clinical intervention.

This algorithm is supplied as part of a Class II medical device, intended for use in clinical settings such as hospitals, emergency rooms, and intensive care units. It operates as a reusable software module integrated into compatible monitor systems, with no specific sterility requirements. The device adheres to FDA 510(k) clearance and EU MDR regulations, and its functionality is validated across multiple monitor models as indicated by the associated FEI numbers.

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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 clinical settings is the EK12 Algorithm designed for, and how does it function in those environments?

    The EK12 Algorithm is designed for use in clinical settings such as hospitals, emergency rooms, and intensive care units. It functions as a software-based analytical tool embedded within physiological patient monitors to detect arrhythmias and generate alarms. This helps clinicians identify abnormal heart rhythms promptly, enabling timely intervention in critical care environments.

  • Is the EK12 Algorithm a standalone device, or is it integrated into another system? If so, what types of systems does it integrate with?

    The EK12 Algorithm is not a standalone device but a reusable software module integrated into compatible physiological patient monitors. It is validated for use across multiple monitor models, as indicated by the extensive list of FEI numbers provided, ensuring compatibility with a broad range of systems.

  • Does the EK12 Algorithm require sterilization, and if not, what are its handling and reuse considerations?

    The EK12 Algorithm does not have specific sterility requirements since it is a software-based component embedded within patient monitors. As a reusable software module, it is designed to be integrated into compatible monitor systems without physical handling or sterilization, ensuring consistent performance across multiple uses.

  • What regulatory pathways has the EK12 Algorithm followed, and what does this mean for its use in the U.S. and EU markets?

    The EK12 Algorithm has followed the FDA 510(k) clearance pathway in the U.S. and adheres to EU MDR (Medical Device Regulation) requirements. This means it has been evaluated for safety and effectiveness under U.S. regulations and meets the necessary standards for commercialization in the European market, ensuring compliance with both jurisdictions.

  • How do I verify if my existing monitor system is compatible with the EK12 Algorithm?

    To verify compatibility, check if your monitor system’s FEI (Facility Equipment Identifier) number appears in the extensive list provided for the EK12 Algorithm. The algorithm is validated for use across multiple monitor models, so if your system’s FEI is included, it is designed to integrate seamlessly with the EK12 Algorithm for arrhythmia detection and alarm generation.