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Cardiac Trigger Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110987

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K110987 FDA 510(k)
FDA Product Code
DRT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A cardiac trigger monitor designed for synchronization of radiographic image acquisition, this device detects and displays the R-wave of the patient’s electrocardiogram (ECG) to enable precise timing for imaging modalities such as nuclear medicine, computed tomography (CT), magnetic resonance (MR), positron emission tomography (PET), and single photon emission computed tomography (SPECT). It functions as a cardiotachometer and rate alarm, providing real-time cardiac monitoring to ensure accurate alignment of imaging with the cardiac cycle.

The device is intended for use in clinical settings requiring precise cardiac gating, such as radiology and nuclear medicine departments. Supplied as a reusable medical instrument, it is not sterile and must be cleaned and maintained according to manufacturer guidelines. The monitor operates in non-MRI environments and is available in multiple model variants, including the 7600 and 7800, each featuring a touchscreen interface for displaying dual ECG vectors and heart rate. Authorized under FDA 510K clearance (K110987), it adheres to regulatory standards for Class II devices (DMS 870.2300)

Frequently asked questions

What clinical settings is this cardiac trigger monitor primarily designed for and how does it improve imaging accuracy?

The Cardiac Trigger Monitor is specifically designed for clinical settings like radiology and nuclear medicine departments where precise cardiac gating is essential. It detects and displays the R-wave of the patient’s ECG in real-time, enabling synchronization of radiographic image acquisition with the cardiac cycle. This ensures accurate alignment of imaging modalities such as CT, MR, PET, and SPECT with the heartbeat, improving the clarity and precision of diagnostic images by reducing motion artifacts.

Is this device single-use or reusable, and what maintenance is required?

This device is supplied as a reusable medical instrument and is not sterile. It must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and hygiene. Since it is not sterile, it should not be used directly on patients without appropriate cleaning and disinfection between uses.

What models are available, and how do their features differ?

The Cardiac Trigger Monitor is available in multiple model variants, including the 7600 and 7800. Both models feature a touchscreen interface for displaying dual ECG vectors and heart rate, but specific differences between the models (e.g., additional functionalities, software updates, or hardware enhancements) are not detailed in the provided data. The models are designed to provide real-time cardiac monitoring for precise cardiac gating in imaging procedures.

Can this device be used in an MRI environment, and if not, why?

No, this device is explicitly designed for use in non-MRI environments. The data does not specify compatibility with MRI systems, and the manufacturer’s guidelines likely emphasize avoiding exposure to magnetic fields, which could interfere with its electronic components or compromise patient safety.

What regulatory pathway was followed for FDA clearance, and what does this indicate about the device’s classification?

The Cardiac Trigger Monitor received FDA clearance through a 510(k) pathway (K110987), classified as a Class II device under DMS 870.2300. This indicates that the device was determined to be substantially equivalent to a legally marketed predicate device and meets regulatory standards for moderate-risk medical devices. The clearance was granted by the FDA’s Cardiovascular (CV) Advisory Committee under a Special 510(k) review, suggesting a thorough evaluation of its safety and effectiveness for its intended use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ivy 7800 Cardiac Trigger Monitor - GE Healthcare, IVY BIOMEDICAL SYSTEMS 7600 OPERATION MANUAL Pdf Download, Model 7600 - Ivy Biomedical Systems Inc - PDF Catalogs | Technical ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ivy Biomedical Systems, Inc.

Sources (1)

  • FDA 510(k) K110987 24 fields · synced Sep 18, 2026