Ge Signa Excite 1.5t 6 Channel Phased Array Flex Coil, Ge Signa Excite 3.0t 6 C…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K042844 FDA 510(k)
- FDA Product Code
- MOS 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 Excite 1.5T and 3.0T 6-Channel Phased Array Flex Coil is a specialty magnetic resonance coil designed for high-resolution imaging in MRI systems. These coils enhance signal reception, improving image clarity and diagnostic accuracy for various anatomical regions by reducing artifacts and increasing sensitivity.
These coils are intended for use with GE Signa Excite MRI systems and are supplied as reusable, non-sterile accessories. They are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance (K042844) and MDR authorization. Compatibility with 1.5T and 3.0T MRI systems ensures optimal performance for radiology applications, with no specific MRI safety restrictions noted beyond standard coil usage.
Frequently asked questions
Are these coils designed for single-use or can they be reused in multiple MRI procedures?
The coils are explicitly labeled as reusable accessories for the GE Signa Excite MRI systems. They are not intended for single-use, but must be handled according to facility protocols for reuse to ensure optimal performance and patient safety.
What MRI field strengths are these coils compatible with, and how does that affect their use?
These coils are designed specifically for use with GE Signa Excite MRI systems operating at 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) field strengths. Compatibility with both strengths ensures flexibility for high-resolution imaging across different clinical applications, though performance may vary slightly depending on the field strength.
Are these coils sterile, and if not, what considerations should be taken for patient safety?
The coils are supplied as non-sterile accessories. Since they are reusable, they must be cleaned, disinfected, and maintained according to facility protocols to prevent contamination and ensure patient safety before each use.
What regulatory pathways have these coils undergone, and how does that impact their use in clinical settings?
The coils have received FDA 510(k) clearance (K042844) under the Special 510(k) pathway and MDR authorization, confirming they meet regulatory standards for safety and effectiveness. This classification ensures they are suitable for radiology applications in MRI systems, though adherence to manufacturer guidelines and facility policies remains essential for proper use.
How should these coils be stored to maintain their performance and longevity?
While specific storage instructions aren’t detailed in the data, reusable MRI coils like these typically require protection from physical damage, extreme temperatures, and electromagnetic interference. Facilities should follow manufacturer recommendations for packaging, handling, and environmental conditions to preserve coil integrity and ensure consistent imaging performance.
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 6 Channel Phased Array Flex Coil, Ge Signa Excite ..., MR Coils-Coil Accessories-Coil Replacement Pads - GE Healthcare, PDF K042844 Ge Signa Excite 1.5t 6 Channel Phased Array Flex Coil, Ge Signa ..., GE Signa Excite 1.5T MRI (11x) - Medical Imaging Source
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K042844 | Class II | Active |
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Manufacturer
- Manufacturer
- Ge Medical Systems, Inc.
Sources (2)
- FDA 510(k) K042844 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026