# K972205: Alpha 7000 Quadrature Wrist Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Sep 5, 1997 after 85 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: 1 generation back to K931008 (1993). 3 ancestors in all.
28 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931008: Model #QWH-63, Quadrature Wrist and Hand Coil, Mri Devices Corp. (1993) Summary page 2.
- K964531: Profile 70000 Quadrature Volume Neck Coil, Us Asia Instruments, Inc. (1997) Summary page 2.
- K945827: Outlook, Philips Medical Systems (Cleveland), Inc. (1995) Summary page 2.

## Most influential descendants
- K023982: Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil (2003), 22 descendants of its own
- 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

## Indications for use
The Alpha 7000 Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand anatomy. The Alpha 7000 Quadrature Wrist Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner. Anatomic Regions: Wrist and hand anatomy Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The GE Signa 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/K972205
Methodology: https://510kreport.com/methodology