# K982972: Signa Profile Small Head Coil

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 16, 1998 after 83 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. The FDA summary names its predicate without a number.
- (no number) Signa Profile Head Coil: named in the summary without a submission number

## Indications for use
The Indications for Use for the Signa Profile Small Head coil expands the imaging capability of the Signa Profile System The small head coil is intended for imaging of the head anatomy and extremities.

Source page: https://510kreport.com/device/K982972
Methodology: https://510kreport.com/methodology