# K100141: 14-Channel Extremity Coil for Magnetom Essenza

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 27, 2010 after 220 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.
12 later devices descend from it; 1 cites it directly.
0 of 29 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 2.

## Most influential descendants
- 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
- K183221: MAGNETOM Amira, MAGNETOM Sempra (2019), 6 descendants of its own

## Indications for use
The intended use of the new 14-Channel Extremity Coil is, in conjunction with THE 1.5T MAGNETOM ESSENZA Magnetic Resonance Scanner, the MR examination of the human knee, foot, ankle, hand and wrist. Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist. The images produced by the MAGNETOM ESSENZA with the 14-Channel Extremity Coil reflects the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The intended use of the MAGNETOM ESSENZA is not affected in any way by the use of the new 14-Channel Extremity Coil.

Source page: https://510kreport.com/device/K100141
Methodology: https://510kreport.com/methodology