Txrx 15ch Knee Coil (1.5t And 3t), Txrx Cp Extremity Coil 3t
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K082636 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)
This device is a Magnetic Resonance, Specialty Coil designed for extremity imaging. The TXRX 15-Channel Knee Coil and TXRX CP Extremity Coil (3T) are transmit-receive coils optimized for high-resolution MRI scans of the knee and other extremities, enabling detailed visualization of soft tissues and bone structures at 1.5T and 3T magnetic field strengths.
The coils are supplied as reusable medical devices intended for use in MRI facilities. They are compatible with MRI systems and must be handled according to manufacturer guidelines to ensure proper functionality and safety. Authorized under FDA 510K and MDR, these coils are classified as Class II devices and are regulated under 21 CFR 892.1000. They require adherence to MRI safety protocols and are not intended for single-use.
Frequently asked questions
Are these coils designed for single-use or can they be reused in multiple MRI procedures?
These coils are explicitly labeled as reusable medical devices and are not intended for single-use. They must be handled according to the manufacturer’s guidelines to ensure proper functionality and safety in MRI facilities, including adherence to MRI safety protocols.
What magnetic field strengths are these coils compatible with, and how does that affect imaging quality?
The TXRX 15-Channel Knee Coil and TXRX CP Extremity Coil (3T) are optimized for 1.5T and 3T magnetic field strengths, enabling high-resolution MRI scans. The transmit-receive design enhances soft tissue and bone structure visualization at both strengths, improving diagnostic clarity for extremity imaging.
How should these coils be stored to maintain their performance and safety?
While the data does not specify exact storage conditions, as reusable MRI coils, they should be stored in a clean, dry environment away from magnetic interference or physical damage. Follow the manufacturer’s guidelines to ensure proper handling, as improper storage could compromise functionality or safety in MRI systems.
What regulatory pathways have these coils undergone, and what classification do they hold?
These coils are Class II devices under 21 CFR 892.1000, authorized via FDA 510K clearance and MDR (Medical Device Regulation). The submission was reviewed by the Radiology (RA) Advisory Committee and deemed substantially equivalent to predicate devices, ensuring compliance with U.S. and EU regulatory standards.
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.
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 | K082636 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quality Electrodynamics
Sources (2)
- FDA 510(k) K082636 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026