# K082636: TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics
- Decided: Sep 25, 2008 after 15 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K893619 (1989). 15 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032633: HRK-63-8 Knee Array Coil, Mri Devices Corp. (2003) Summary page 2.
- K050299: HRK-123 Knee Array Coil, Mri Devices Corporation (2005) Summary page 2.
- K023982: Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil, Usa Instruments, Inc. (2003) Summary page 2.

## Most influential descendants
- K100141: 14-Channel Extremity Coil for Magnetom Essenza (2010), 12 descendants of its own
- K130262: Magnetom Essenza with Syngo MR D14 (2013), 11 descendants of its own
- K152283: MAGNETOM Amira (2015), 9 descendants of its own
- K173600: MAGNETOM Amira (2017), 7 descendants of its own
- K163211: MAGNETOM Sempra with syngo MR E11S (2017), 7 descendants of its own

## Recalls of this device
- Aug 20, 2019 · Class II · Z-0031-2020: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- Aug 20, 2019 · Class II · Z-0037-2020: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- Aug 20, 2019 · Class II · Z-0033-2020: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- Aug 20, 2019 · Class II · Z-0036-2020: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- Aug 20, 2019 · Class II · Z-0032-2020: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- Aug 20, 2019 · Class II · Z-0034-2020: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- Aug 20, 2019 · Class II · Z-0035-2020: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- Jul 27, 2012 · Class II · Z-2314-2012: On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.

## Indications for use
For use with a 1.5T Siemens Avanto/Espree or 3T Siemens TrioNerio magnetic resonance scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K082636
Methodology: https://510kreport.com/methodology