# K023982: Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Feb 21, 2003 after 81 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: 3 generations back to K893619 (1989). 12 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002179: Magnetom Allegra System, Siemens Medical Solutions USA, Inc. (2000)
- K971246: Leo 7000 Quadrature Knee Coil, Usa Instruments, Inc. (1997) Summary page 2.
- K001210: HI-Res 9000 Phased Array Carotid Coil, Usa Instruments, Inc. (2000) Summary page 2.
- K972205: Alpha 7000 Quadrature Wrist Coil, Usa Instruments, Inc. (1997) Summary page 4.

## Most influential descendants
- K082636: TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T (2008), 21 descendants of its own
- 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

## Indications for use
The Leo Ill Tx/Rx Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee and surrounding anatomy. The Alpha Ill Tx/Rx Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand. The Leo Ill Tx/Rx Quadrature Knee Coil and the Alpha 111 Tx/Rx Quadrature Wrist Coil are designed for use with the Siemens Magnetom Trio 3.OT scanner manufactured by Siemens Medical Solutions. Anatomic Regions: Leo 111 Tx/Rx Quadrature Knee Coil: Knee and surrounding Anatomy Alpha IIII Tx/Rx Quadrature Wrist Coil: Wrist and Hand Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The 3.OT MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K023982
Methodology: https://510kreport.com/methodology