# K113280: Carotid Coil GE 1.5T

- Pathway: 510(k) (Traditional)
- Applicant: Tursiop Technologies, LLC
- Decided: Nov 23, 2011 after 16 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: 7 generations back to K893619 (1989). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083434: TT1 General Purpose Coil, Tursiop Technologies, LLC (2008) Summary page 3.
- (no number) GE 3-inch General Purpose Coil: named in the summary without a submission number

## Indications for use
The Carotid Coil GE1..ST is a receive~only .2-channel diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Twinspeed HDx 1.ST MRI scanner/system. It is used for obtaining diagnostic images of the carotid arteries in the region of the neck and lower c&r.anium.

Source page: https://510kreport.com/device/K113280
Methodology: https://510kreport.com/methodology