# K030953: GE 3.0T General Purpose Flex Coil

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, Inc.
- Decided: Apr 10, 2003 after 14 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 K923264 (1992). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923264: General Purpose Flex Coil, General Electric Co. (1992) Summary page 1.

## Most influential descendants
- K061715: Mrgfus General Purpose and Breast Coil (2006), 2 descendants of its own
- K083434: TT1 General Purpose Coil (2008), 1 descendant of its own
- K123681: 1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex Coil (2013), 0 descendants of its own
- K113280: Carotid Coil GE 1.5T (2011), 0 descendants of its own

## Indications for use
The GE 3.OT General Purpose Flex Coil is designed to facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh. The GE 3.OT General Purpose Flex Coil will facilitate dynamic MR imaging of the joints of lower extremity (Knee and Ankle). This coil consists of two 5” x 6.5” surface coils coupled as a Helmholtz pair in a flexible package that can be wrapped around the anatomy of interest. This flexibility allows for the coil to be applied to a wider range of patients when compared to a similar coil in a rigid package. The coil is an option to the GE Signa@3.OT whole body MR System.

Source page: https://510kreport.com/device/K030953
Methodology: https://510kreport.com/methodology