# K200836: 8ch Flex Suite

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen RF Tech Co., Ltd.
- Decided: Jul 22, 2020 after 113 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 K101632 (2010). 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)
- K172222: 8ch Flex Suite, Shenzhen RF Tech Co., Ltd. (2017) Summary page 4.

## Indications for use
The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head, spine and cardiac that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K200836
Methodology: https://510kreport.com/methodology