# K042207: 11000 Rapture Phased Array Peripheral Vascular Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Aug 26, 2004 after 10 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: 3 generations back to K964813 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K010730: Modification to Flow 7000 Peripheral Vascular Coil, Usa Instruments, Inc. (2001) Summary page 2.
- K023247: Champion 5000 Peripheral Vascular Coil, Usa Instruments, Inc. (2002) Summary page 2.

## Indications for use
The Rapture 11000 a phased array peripheral vascular coil is a multi-element phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy extending from below the knee to the foot region, in Magnetic Resonance Imaging Systems. The Rapture 11000 Coil is designed for use with the Signa 1.5T MRI system manufactured by GE Healthcare Technologies.

Source page: https://510kreport.com/device/K042207
Methodology: https://510kreport.com/methodology