# K964141: GE Sterile Disposable Equipment Coil Cover

- Pathway: 510(k) (Traditional)
- Applicant: Contour Fabricators, Inc.
- Decided: Jan 30, 1997 after 107 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 K782155 (1979). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K782155: General Equipment Cover, Contour Fabricators, Inc. (1979) Summary page 1.

## Indications for use
The GE Sterile Disposable Equipment Cover is intended to protect equipment from fluids. Specifically, a coil used in the GE Magnetic Resonance Imaging (MRI) System.

Source page: https://510kreport.com/device/K964141
Methodology: https://510kreport.com/methodology