# K123681: 1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex Coil

- Pathway: 510(k) (Traditional)
- Applicant: Wipro GE Healthcare Private, Ltd.
- Decided: Feb 22, 2013 after 84 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: 2 generations back to K923264 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030953: GE 3.0T General Purpose Flex Coil, Ge Medical Systems, Inc. (2003) Summary page 1.

## Indications for use
The Flex Coils are designed to produce diagnostic images of human anatomnies and are used as general purpose coils. The Flex Coils are receive-only coils designed to be used with 1.5T MRI systems manufactured by GE Healthcare to provide images of various parts of human body including shoulder, elbow, wrist, knee, hip and ankle. Large flex coil can be used for scanning large anatomy and small flex coil can be used for scanning smaller anatomy. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.

Source page: https://510kreport.com/device/K123681
Methodology: https://510kreport.com/methodology