# K024187: Spirit Iii Totalsense Cardiac Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Feb 4, 2003 after 47 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 K001209 (2000). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013594: Body Array Coil, Usa Instruments, Inc. (2002)
- K001209: Insight Plus 9000 Phased Array Torso and Pelvis Coil, Usa Instruments, Inc. (2000) Summary page 2.

## Most influential descendants
- K031172: Spirit Iii Totalsense Cardiac Coil (2003), 1 descendant of its own
- K033490: Spirit 5000 Cardiac Coil (2004), 0 descendants of its own

## Indications for use
The Spirit III TotalSENSE Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Siemens Magnetom Trio 3.0T MRI scanner manufactured by Siemens Medical Solutions, Inc. Anatomic Regions: Cardiovascular system Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The 3.0T 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/K024187
Methodology: https://510kreport.com/methodology