# K023247: Champion 5000 Peripheral Vascular Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Dec 23, 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: 2 generations back to K964813 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982339: Flow 7000 Peripheral Vascular Coil, Usa Instruments, Inc. (1998) Summary page 2.

## Most influential descendants
- K042207: 11000 Rapture Phased Array Peripheral Vascular Coil (2004), 0 descendants of its own

## Indications for use
The Champion 5000 Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the vasculature and soft tissue anatomy, extending from the torso to the foot region. Champion 5000 Peripheral Vascular Coil is designed for use with the Hitachi Altaire 0.7T scanner manufactured by Hitachi Medical Systems America, Inc. Anatomic Regions: vasculature and soft tissue anatomy, extending from the torso to the foot region. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The 1.5T 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 T I, 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/K023247
Methodology: https://510kreport.com/methodology