# K051618: Special Procedures II Head Coil, Model 1400GE-64

- Pathway: 510(k) (Traditional)
- Applicant: Midwest Rf, LLC
- Decided: Aug 2, 2005 after 46 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 and Proton Spectroscopy of the anatomy of head and brain. This device is used in conjunction with a General Electric 1.5 Tesla MRI Scanner. Proton Spectroscopy is used in conjunction with the PROBE (Proton Brain Exam) option.

Source page: https://510kreport.com/device/K051618
Methodology: https://510kreport.com/methodology