TxRx Knee 15 Flare MR Coil 3.0T
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163066 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 TxRx Knee 15 Flare MR Coil 3.0T is a Coil, Magnetic Resonance, Specialty designed for use in magnetic resonance imaging (MRI) systems operating at 3.0 Tesla. This device is engineered to enhance signal reception and transmission for knee imaging, providing high-resolution diagnostic images of soft tissues, ligaments, and cartilage in the knee joint.
Supplied as a reusable component, the coil is intended for use in MRI environments and must comply with strict electromagnetic compatibility and safety standards for 3.0T systems. It is authorized under FDA 510K and MDR, with a classification as a Class II device. The coil is not single-use and requires proper handling, storage, and maintenance in accordance with MRI facility protocols to ensure optimal performance and patient safety.
Frequently asked questions
Is the TxRx Knee 15 Flare MR Coil 3.0T designed for single-use or can it be reused in MRI procedures?
The TxRx Knee 15 Flare MR Coil 3.0T is explicitly designed as a reusable component for MRI systems operating at 3.0 Tesla. Since it is not labeled as single-use, it must be properly cleaned, maintained, and stored according to MRI facility protocols to ensure safety, performance, and compliance with electromagnetic compatibility standards.
What types of knee structures does this coil enhance imaging for, and why is the '15 Flare' designation important?
The TxRx Knee 15 Flare MR Coil 3.0T is engineered to improve signal reception and transmission for high-resolution imaging of soft tissues, ligaments, and cartilage in the knee joint. The '15 Flare' designation refers to the coil’s flared design, which helps optimize coverage and signal clarity for knees with varying anatomical shapes, particularly those with wider flare angles, ensuring better diagnostic detail.
How is this coil authorized for use, and what regulatory pathways does it follow?
The TxRx Knee 15 Flare MR Coil 3.0T is authorized under FDA 510(k) clearance and the EU Medical Device Regulation (MDR). It is classified as a Class II device in the U.S. and follows traditional 510(k) review with a substantially equivalent determination by the FDA’s Radiology Devices Panel. The coil must comply with strict electromagnetic compatibility and safety standards for 3.0T MRI systems.
What storage and handling requirements should be followed for this reusable coil?
Since the TxRx Knee 15 Flare MR Coil 3.0T is reusable, it must be stored in a clean, dry, and protected environment to prevent damage or contamination. Facility protocols should include regular cleaning, calibration checks, and adherence to MRI safety guidelines to maintain electromagnetic compatibility and ensure optimal performance for repeated use.
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 | K163066 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quality Electrodynamics Llc
- FDA Applicant
- Quality Electrodynamics, LLC
Sources (2)
- FDA 510(k) K163066 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026