# K971668: Signa Profile Wrist Coil and Mobile Siting Options

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jul 24, 1997 after 79 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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 System: named in the summary without a submission number
- (no number) Signa Profile Extremity Coil: named in the summary without a submission number

## Indications for use
The Indications for Use for the Motile Siting option of Signa Profile System is the same as for a Fixed Site System. The Wrist Coil expands the capability of the Signa Profile System. It accommodates and improves imaging of the wrist and surrounding structures.

Source page: https://510kreport.com/device/K971668
Methodology: https://510kreport.com/methodology