# K033490: Spirit 5000 Cardiac Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Jan 9, 2004 after 66 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: 4 generations back to K001209 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031172: Spirit Iii Totalsense Cardiac Coil, Usa Instruments, Inc. (2003) Summary page 2.
- K000437: Interventional Body Coil, Usa Instruments, Inc. (2000) Summary page 2.

## Indications for use
The Spirit 5000 Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit 5000 Cardiac Coil is designed for use with the Hitachi Altaire 0.7T MR scanner manufactured by Hitachi Medical Systems, Inc. The indications for use are the same as for standard imaging: The 0.7T 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/K033490
Methodology: https://510kreport.com/methodology