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Cardiac Trigger Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K202138

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K202138 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)

The Cardiac Trigger Monitor is a medical device classified as a Cardiotachometer and Rate Alarm, designed to monitor and display patient electrocardiogram (ECG) waveforms and heart rate. It provides real-time R-wave detection to synchronize imaging modalities, ensuring precise cardiac gating for diagnostic procedures such as nuclear medicine, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and single photon emission computed tomography (SPECT).

This device is intended for use in clinical settings where cardiac synchronization is critical, such as radiology and nuclear medicine departments. It operates as a reusable, non-sterile medical instrument and is classified under FDA regulation number 870.2300 as a Class II device, with FDA 510K clearance under K202138. The monitor is designed for integration with various imaging systems and requires proper calibration and maintenance as specified in manufacturer documentation.

Frequently asked questions

What clinical settings is the Cardiac Trigger Monitor designed for, and how does it improve diagnostic procedures?

The Cardiac Trigger Monitor is specifically designed for clinical settings like radiology and nuclear medicine departments where precise cardiac synchronization is essential. It monitors and displays ECG waveforms in real-time, using R-wave detection to synchronize imaging modalities such as CT, MRI, PET, and SPECT. This ensures accurate cardiac gating during diagnostic procedures, improving image clarity and diagnostic accuracy by aligning imaging data with the patient’s heartbeat.

Is the Cardiac Trigger Monitor intended for single-use or reusable applications, and what does this mean for maintenance?

The Cardiac Trigger Monitor is a reusable, non-sterile medical device. This means it is built for repeated use in clinical environments but does not require sterile packaging for each procedure. Proper calibration and maintenance, as outlined in the manufacturer’s documentation, are critical to ensure reliable performance and accuracy over time.

How is the Cardiac Trigger Monitor integrated with other imaging systems, and what compatibility considerations should clinicians keep in mind?

The Cardiac Trigger Monitor is designed to integrate with various imaging systems, including CT, MRI, PET, and SPECT scanners, to provide real-time cardiac synchronization. While the device is compatible with multiple modalities, clinicians should verify compatibility with their specific imaging equipment and follow manufacturer guidelines for proper setup, calibration, and connection protocols to ensure seamless operation.

What regulatory pathway was followed for FDA clearance of the Cardiac Trigger Monitor, and what does this mean for its use in clinical practice?

The Cardiac Trigger Monitor received FDA clearance through a 510(k) premarket notification process, specifically under the traditional pathway with a decision code of 'SE' (Substantially Equivalent) and advisory committee review by the Cardiovascular panel. This clearance indicates that the device meets FDA standards for safety and effectiveness as a Class II medical device under regulation number 870.2300, allowing it to be legally marketed and used in clinical practice for its intended purpose.

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 Biomedical Systems, Inc. Welcome, Ivy Biomedical Model 3000 Series Cardiac Trigger Monitor ... - Manuals+, Ivy Biomedical Cardiac Trigger Monitor User Manual

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) K202138 24 fields · synced Sep 18, 2026