# K090267: SV DBS Brain Array, Model 1500SV-SMS64

- Pathway: 510(k) (Traditional)
- Applicant: Midwest Rf, LLC
- Decided: Mar 16, 2009 after 41 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 2D and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem. This device is used in conjunction with a Siemens Medical Systems 1.5 Tesla MRI Scanner with Total imaging matrix (Tim) option.

Source page: https://510kreport.com/device/K090267
Methodology: https://510kreport.com/methodology