Identifiers
- 510(k) Number
- K192852 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MRI ECG Patient Cable is a Class II medical device designed for use in nuclear magnetic resonance imaging (MRI) systems. It facilitates the transmission of electrocardiogram (ECG) signals from patients to external monitoring equipment, ensuring synchronized cardiac gating during MRI scans.
This cable is intended for single-use in radiology settings and is compatible with MRI environments. It is supplied sterile and must be used in accordance with MRI safety guidelines. The device is authorized under FDA 510(k) clearance (K192852) and adheres to regulatory standards for Class II devices, including those outlined in 21 CFR 892.1000.
Frequently asked questions
What is the primary purpose of the MRI ECG Patient Cable in a clinical setting?
The MRI ECG Patient Cable is designed to transmit electrocardiogram (ECG) signals from patients to external monitoring equipment during nuclear magnetic resonance imaging (MRI) scans. This ensures synchronized cardiac gating, which helps align the MRI imaging process with the patient’s heartbeat for clearer and more precise diagnostic images.
Is the MRI ECG Patient Cable intended for reuse, or is it meant to be used only once?
The MRI ECG Patient Cable is explicitly intended for single-use in radiology settings. This design choice aligns with best practices for maintaining patient safety and sterility in clinical environments, particularly where reusable devices could pose contamination risks.
How is the MRI ECG Patient Cable supplied, and is it sterile?
The cable is supplied sterile and packaged for single-use. This ensures it meets the hygiene standards required for use in MRI environments, where contamination could compromise diagnostic accuracy or patient safety.
What regulatory pathway was followed for FDA clearance of this device?
The MRI ECG Patient Cable received FDA 510(k) clearance under the traditional review pathway, with a decision code indicating it was determined to be substantially equivalent to a predicate device. The clearance number is K192852, and it falls under the regulatory classification of Class II medical devices, governed by 21 CFR 892.1000.
Are there specific MRI safety guidelines I need to follow when using this cable?
Yes, the MRI ECG Patient Cable must be used in accordance with MRI safety guidelines, as it is explicitly designed for compatibility with MRI environments. These guidelines ensure the cable does not interfere with the MRI system or pose risks to patients during imaging. Always refer to the manufacturer’s instructions and facility protocols for proper handling.
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 MRI ECG Cable - allmed.wiki, Ivy Biomedical Systems, Inc. FDA 510(k) Products - Latest 2024
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192852 | Class II | Active |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA 510(k) K192852 24 fields · synced Sep 18, 2026