# K041921: GE Signa Profile 6 Inch GP Coil

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Jul 26, 2004 after 10 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 K972296 (1997). 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)
- K972296: Magnetic Resonance Diagnostic System, Ge Medical Systems, Inc. (1997) Summary page 1.

## Indications for use
The GE 0.2T 6-inch GP Coil is a 2-turn solenoid receive only coil designed for MR imaging. The coil has a soft pad, which helps to place the position to be examined in the center of the coil and provides comfort as well. The coil is a general-purpose coil that can be used to image the Cervical Spine, the neck, shoulder, and other extremity anatomy. The coil connects to the Signa Profile MRI system by way of the interface connector.

Source page: https://510kreport.com/device/K041921
Methodology: https://510kreport.com/methodology