Identifiers
- 510(k) Number
- K170828 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 Class II medical device classified as a Cardiotachometer and Rate Alarm, designed to detect and monitor cardiac electrical activity. It provides real-time R-wave synchronization, enabling precise timing for diagnostic imaging 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 departments and nuclear medicine facilities. Supplied as a reusable device, it requires proper sterilization and maintenance to ensure accuracy and reliability. The monitor operates within MRI-safe parameters for compatible imaging modalities and is authorized under FDA 510(k) clearance (K170828). Multiple model variants are available, as indicated by the registration numbers (e.g., 3000126629, 3008717264).
Frequently asked questions
What clinical settings is the Cardiac Trigger Monitor designed for and why?
The Cardiac Trigger Monitor is specifically designed for clinical settings like radiology departments and nuclear medicine facilities where precise cardiac synchronization is essential. It detects and monitors cardiac electrical activity in real-time, providing R-wave synchronization to ensure accurate timing for diagnostic imaging procedures such as nuclear medicine, CT, MRI, PET, and SPECT scans. This synchronization helps align imaging data with the cardiac cycle, improving diagnostic accuracy for procedures that rely on cardiac phase alignment.
Is the Cardiac Trigger Monitor reusable, and what sterilization or maintenance is required?
Yes, the Cardiac Trigger Monitor is a reusable device. Since it is intended for repeated use, it requires proper sterilization and maintenance to ensure reliability and accuracy. The manufacturer, Ivy Biomedical Systems, Inc., likely provides guidelines for cleaning, disinfection, and sterilization protocols to maintain its performance and safety for clinical use.
How many model variants of the Cardiac Trigger Monitor are available, and how can I identify them?
The Cardiac Trigger Monitor comes in multiple model variants, each identified by unique registration numbers. These include models like 3000126629, 3008717264, and several others listed in the regulatory records. These numbers are used for tracking and compliance purposes, but the specific features or differences between models are not detailed in the provided data. You can confirm the exact model and its specifications by referencing the manufacturer’s documentation or contacting Ivy Biomedical Systems, Inc.
Can the Cardiac Trigger Monitor be used safely in MRI environments, and what imaging modalities does it support?
Yes, the Cardiac Trigger Monitor is designed to operate within MRI-safe parameters for compatible imaging modalities. It is specifically intended for use in procedures like MRI, CT, PET, and SPECT, where precise cardiac synchronization is critical. The device’s MRI-safe design ensures it can be used alongside these imaging techniques without compromising safety or performance.
What regulatory pathway was followed for the Cardiac Trigger Monitor’s clearance, and who should I contact for more details?
The Cardiac Trigger Monitor was cleared through the FDA’s 510(k) pathway, specifically under the classification of a Cardiotachometer and Rate Alarm, with an abbreviated clearance type (K170828). It was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device. For further details, you can contact Nicole Bush at Ivy Biomedical Systems, Inc. at their address in Branford, CT, or via the provided contact information in the regulatory records.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170828 | Class II | Active |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA 510(k) K170828 24 fields · synced Sep 18, 2026