EK12 V2 Algorithm

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

510(k) Number

K221904 ↗

FDA product code

MHX

Device class

Class II

Regulation

21 CFR Part 870.1025

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

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See all devices from GE Medical Systems Information Technologies, Inc. →

• What types of cardiac monitors is the EK12 V2 Algorithm designed to integrate with, and how does it function within those systems?

  The EK12 V2 Algorithm is a software-based solution designed to integrate as an advanced arrhythmia detection system into compatible cardiac monitors that require continuous physiological patient monitoring. It analyzes real-time ECG signals to identify and alert clinicians to abnormal heart rhythms, such as arrhythmias, without requiring physical hardware changes. Since it operates as a reusable software component, it must be installed on systems already cleared for physiological monitoring with arrhythmia detection capabilities.

• Is the EK12 V2 Algorithm a single-use or reusable component, and what are the implications for its maintenance?

  The EK12 V2 Algorithm is explicitly described as a reusable software component, meaning it is not discarded after a single use. As software, its maintenance involves updates or reinstallations on compatible ECG monitoring systems, rather than physical replacement. No sterility requirements are specified, as it is not a physical device exposed to sterile environments.

• What regulatory pathways does the EK12 V2 Algorithm follow, and which governing bodies have approved its use?

  The EK12 V2 Algorithm is cleared under the FDA’s Traditional 510(k) pathway and adheres to the EU’s Medical Device Regulation (MDR). It is classified as a Class II device under OpenFDA’s Physiological Patient Monitor category with Arrhythmia Detection or Alarms. Clearance was granted by the FDA’s Cardiovascular (CV) Advisory Committee, and the device is filed under product code MHX with regulation number 870.1025.

• Does the EK12 V2 Algorithm have any compatibility restrictions with other medical devices, such as MRI machines?

  The EK12 V2 Algorithm does not specify any compatibility with MRI machines, nor does it mention MRI safety considerations. Since it is a software-based component for cardiac monitors, its functionality depends entirely on the host system’s hardware and software environment. Clinicians should confirm compatibility with their specific ECG monitoring systems before integration.

• How does one determine if their existing cardiac monitoring system can support the EK12 V2 Algorithm?

  To determine compatibility, check if your system is listed among the OpenFDA registration numbers (e.g., 3021219789, 3013500228, etc.) associated with the EK12 V2 Algorithm. These identifiers correspond to cleared physiological patient monitors with arrhythmia detection capabilities. Contact GE Medical Systems Information Technologies, Inc. (address: 9900 Innovation Dr., Wauwatosa, WI 53226) or their technical support team for confirmation, as software integration may require specific system configurations.