# K163066: TxRx Knee 15 Flare MR Coil 3.0T

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics, LLC
- Decided: Nov 29, 2016 after 27 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K893619 (1989). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082636: TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T, Quality Electrodynamics (2008) Summary page 4.

## Indications for use
The TxRx Knee 15 Flare MR Coil 3.0T is intended for use with Siemens 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K163066
Methodology: https://510kreport.com/methodology