# K013594: Body Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Jan 22, 2002 after 84 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 K001209 (2000). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001209: Insight Plus 9000 Phased Array Torso and Pelvis Coil, Usa Instruments, Inc. (2000) Summary page 2.
- K002482: Vision 9000 Phased Array Torso Coil, Usa Instruments, Inc. (2000) Summary page 2.

## Most influential descendants
- K024187: Spirit Iii Totalsense Cardiac Coil (2003), 2 descendants of its own
- K031172: Spirit Iii Totalsense Cardiac Coil (2003), 1 descendant of its own
- K030371: Prima Iii Totalsense Torso Coil (2003), 1 descendant of its own
- K103365: Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array Coil (Posterior); Discovery 3T 32 CH Body a (2011), 0 descendants of its own
- K033490: Spirit 5000 Cardiac Coil (2004), 0 descendants of its own

## Indications for use
The Body Array Coil is designed to provide Magnetic Resonance Images of the torso region including the abdomen, thoracic, and lumbar spine anatomy. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla scanner. The indications for use are the same as for standard imaging: The Siemens Rhapsody 1.0Tesla 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/K013594
Methodology: https://510kreport.com/methodology