TxRx Knee 15 Flare MR Coil 1.5T

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K162966

Identifiers

510(k) Number: K162966 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 transmit/receive, 15-channel phased array RF coil for magnetic resonance imaging (MRI), classified under the nomenclature for Coil, Magnetic Resonance, Specialty. It is designed to capture radiofrequency signals from the knee anatomy, enabling high-resolution imaging of the knee joint during MRI procedures at 1.5 Tesla.

The TxRx Knee 15 Flare MR Coil 1.5T is supplied as a reusable accessory for Siemens 1.5T MRI systems and is intended for use in radiology settings. It has been granted FDA 510(k) clearance under the Traditional pathway and complies with MDR (Medical Device Regulation) requirements. The device is non-sterile and must be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and MRI safety.

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: TxRx Knee 15 Flare MR Coil 1.5T (K162966) — FDA 510 (k) | Innolitics, TxRx Knee 15 Flare MR Coil 1.5T - BEUDAMED, 10676687-TxRx Knee15 Flare MR Coil Set 1.5T - Mediram

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K162966	Class II	Active

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Manufacturer

Manufacturer: Quality Electrodynamics Llc
FDA Applicant: Quality Electrodynamics, LLC

Sources (2)

FDA 510(k) K162966 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026