# K982339: Flow 7000 Peripheral Vascular Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Sep 4, 1998 after 60 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 K964813 (1997). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K964813: Model 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower Extremity Flexible Array and Model 538GE-64:, Medical Advances, Inc. (1997) Summary page 2.

## Most influential descendants
- K023247: Champion 5000 Peripheral Vascular Coil (2002), 1 descendant of its own
- K042207: 11000 Rapture Phased Array Peripheral Vascular Coil (2004), 0 descendants of its own

## Indications for use
The Flow 7000 Phased Array Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the abdominal aorta,peripheral vasculature and soft tissue anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR’s Signa 1.5T scanner. Anatomic Regions: Abdominal Vasculature, Peripheral Vasculature and soft tissue Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Signa 1.5T 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/K982339
Methodology: https://510kreport.com/methodology