GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K041476 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 GE Signa Excite 1.5T MR System and GE Signa Excite 3.0T MR System are nuclear magnetic resonance imaging systems. These devices are designed to produce diagnostic images of the body through magnetic resonance technology.
These systems are intended for use in clinical radiology settings. They are regulated under FDA 510(k) clearance as Class 2 medical devices.
Frequently asked questions
What is the primary purpose of the GE Signa Excite MR systems?
These systems are nuclear magnetic resonance imaging devices intended for use in clinical radiology settings to produce diagnostic images of the human body.
What is the regulatory status of these imaging systems?
The GE Signa Excite 1.5T and 3.0T MR systems are regulated as Class 2 medical devices and have received FDA 510(k) clearance.
Are there different field strengths available for this model?
Yes, the system is available in two distinct configurations: the GE Signa Excite 1.5T MR System and the GE Signa Excite 3.0T MR System, both of which utilize magnetic resonance technology for diagnostic imaging.
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: GE Signa Excite 1.5T MRI (11x) - Medical Imaging Source, Magnetic Resonance Imaging (MRI) Solutions - GE Healthcare, GE Signa Excite 1.5T MRI Operator Manual - Medical Imaging Source, SIGNA 1.5T MRI scanners | GE HealthCare (United States)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041476 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
Sources (1)
- FDA 510(k) K041476 24 fields · synced Oct 6, 2026