# K031143: Alpha 5000 Wrist Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: May 29, 2003 after 49 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: 2 generations back to K931008 (1993). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972205: Alpha 7000 Quadrature Wrist Coil, Usa Instruments, Inc. (1997) Summary page 2.

## Most influential descendants
- K072935: Speeder 1.5T Wrist Array Coil (2007), 2 descendants of its own
- K083014: Atlas Speeder Head/Cervical Coil, Model Mjah-137A (2008), 1 descendant of its own
- K121910: Octave Speeder Head (2012), 0 descendants of its own

## Indications for use
The Alpha 5000 Wrist Coil is designed to provide Magnetic Resonance Images of the hand and wrist. The Alpha 5000 Wrist Coil is designed for use with the Toshiba OPART 0.35T MR scanner manufactured by Toshiba Medical Systesm, Inc. Anatomic Regions: Wrist and hand Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The 0.35T 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/K031143
Methodology: https://510kreport.com/methodology