# K111259: SV DBS Vrain Array

- Pathway: 510(k) (Traditional)
- Applicant: Midwest Rf, LLC
- Decided: Jul 5, 2011 after 62 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The 20 and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem, This device is used in conjunction with a GE Medical Signa HDx 1.5 T closed, horizontal bore MRI system capable of utilizing at least 8 channel Phased Array receive-only coils with integrated pre-amplifiers.

Source page: https://510kreport.com/device/K111259
Methodology: https://510kreport.com/methodology