Signa MFO/I Magnetic Resonance System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002611 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 Signa MFO/I Magnetic Resonance System is a nuclear magnetic resonance imaging device designed for whole-body diagnostic imaging. It employs magnetic resonance technology to generate detailed images of internal body structures, aiding in the diagnosis of various medical conditions through high-resolution soft tissue contrast and multiplanar imaging capabilities.
This system is intended for use in radiology departments and clinical settings where MRI scans are performed. It is a reusable, non-sterile device with specific MRI safety classifications, including designated field-of-view and magnetic field strength parameters. The system operates under FDA 510(k) clearance (K002611) and adheres to regulatory standards outlined in 21 CFR 892.1000. Multiple registration numbers and product codes (e.g., LNH) are associated with its compliance and tracking.
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: Magnetic Resonance Imaging (MRI) Solutions - GE Healthcare, K002611 FDA 510(k) - SIGNA MFO/I MAGNETIC RESONANCE SYSTEM, SIGNA MFO/I MAGNETIC RESONANCE SYSTEM - Innolitics, Präsentationssysteme & Großformatdruck aus einer Hand | Signa Shop, PDF GE Medical Systems - accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002611 | Class II | Active |
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Manufacturer
- Manufacturer
- Ge Medical Systems
Sources (1)
- FDA 510(k) K002611 24 fields · synced Oct 6, 2026