1.5t Signa Hdxt 3.0t Signa Hdxt Signa Vibrant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121676 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 1.5T Signa HDxt 3.0T Signa HDxt Signa Vibrant is a nuclear magnetic resonance imaging system used for clinical imaging. It features a homogeneous magnet with a 48-cm field of view and offers 8, 16, and 32 channel RF options with HD gradients for high-fidelity waveforms.
This system is supplied for use in radiology departments and is regulated under FDA 510K clearance with product code LNH. It is a Class II device that includes various models with different field strengths and configurations for diagnostic imaging purposes.
Frequently asked questions
What is the Signa HDxt MRI system used for?
The Signa HDxt is a nuclear magnetic resonance imaging system used for clinical diagnostic imaging in radiology departments. It features a homogeneous magnet with a 48-cm field of view and offers various channel RF options with HD gradients for high-fidelity waveforms.
What are the available configurations for the Signa HDxt system?
The system is available in multiple models with different field strengths, including 1.5T and 3.0T options. It also offers various RF channel configurations (8, 16, and 32 channels) with HD gradients for different imaging needs.
How is the Signa HDxt MRI system supplied?
The system is supplied for use in radiology departments as a Class II medical device. It is regulated under FDA 510K clearance with product code LNH and is designed for diagnostic imaging purposes.
What regulatory approvals does the Signa HDxt have?
The Signa HDxt MRI system has received FDA 510K clearance with product code LNH. It is classified as a Class II device and was determined to be substantially equivalent to predicate devices through the traditional clearance process.
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 HDxt 1.5T 3.0T MRI - Clinical Imaging Systems, GE Healthcare HDxt & VIBRANT Manual | PDF | Computer Keyboard ... - Scribd, 1.5T SIGNA™ HDxt SIGNA™ Works Edition - GE Healthcare
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121676 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
Sources (1)
- FDA 510(k) K121676 24 fields · synced Oct 6, 2026