# K252876: GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen RF Tech Co., Ltd.
- Decided: Apr 1, 2026 after 203 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 K103342 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103342: 3.0T Metaflexcoil, Neocoil, LLC (2010) Summary page 5.

## Indications for use
The 3.0T GEM Flex Suite manufactured by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general-purpose coil. It include of three coils: 16-L Array, 16-M Array, and 16-S Array. The 3.0T GEM Flex Suite is designed for use with GEHC 3.0T MRI systems to produce diagnostic images of the Head, Torso, Hip, Spine, Shoulder,Knee, Foot, Ankle, Elbow, and Wrist that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K252876
Methodology: https://510kreport.com/methodology