Modification to 3.0T Signa VH/I Magnetic Resonance System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K003575 FDA 510(k)
- FDA Product Code
- LNI 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)
This device is a System, Nuclear Magnetic Resonance Spectroscopic (product code LNI), designed for high-field magnetic resonance imaging (MRI) at 3.0 Tesla. It generates detailed images of internal body structures using strong magnetic fields and radio waves, enabling diagnostic evaluation of soft tissues, organs, and vascular systems in radiology settings.
The Modification to 3.0T Signa VH/I is intended for use in clinical MRI environments and has received FDA 510(k) clearance under Traditional review by the Radiology Advisory Committee. It is classified as a Class II device under special controls and is supplied as a reusable system. No new indications or hazards were introduced in this modification, adhering to existing regulatory and safety standards for MRI technology.
Frequently asked questions
What is the primary purpose of the MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM, and where is it typically used?
This device is a 3.0 Tesla MRI system designed for high-field magnetic resonance imaging (MRI), enabling detailed visualization of soft tissues, organs, and blood vessels. It is intended for use in clinical radiology settings to aid diagnostic evaluations, such as identifying abnormalities in internal structures.
Is the MODIFICATION TO 3.0T SIGNA VH/I a single-use or reusable device, and how is it supplied?
The system is reusable, meaning it is designed for repeated use in clinical environments after proper maintenance and cleaning. It is supplied as a complete MRI system, not as a disposable component, and requires adherence to manufacturer guidelines for longevity and safety.
What regulatory pathway was followed for this modification, and which advisory committee was involved?
This modification received FDA 510(k) clearance under Traditional review, reviewed by the Radiology Advisory Committee (RA). The device was deemed substantially equivalent to a predicate, adhering to existing safety and performance standards for MRI technology.
Does this device come in different sizes or models, and how would I identify the correct configuration for my needs?
The provided data lists multiple registration numbers (FEI numbers), which correspond to different configurations or variants of the 3.0T SIGNA VH/I system. These variations may include differences in software, coils, or other accessories. To determine the correct model, consult GE Medical Systems’ documentation or a sales representative, as the exact specifications vary by registration number.
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: Modification to 3.0t Signa Vh/I Magnetic Resonance System, 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM - fda.innolitics.com, K003575 FDA 510(k) - MODIFICATION TO 3.0T SIGNA VH/I MAGNETI..., PDF K003575 Modification to 3.0t Signa Vh/I Magnetic Resonance System, Modification to 3.0t Signa Vh/I Magnetic Resonance System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003575 | Class II | Active |
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Manufacturer
- Manufacturer
- Ge Medical Systems
Sources (1)
- FDA 510(k) K003575 24 fields · synced Oct 6, 2026