# K252587: HD 8Ch Wrist Array

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen RF Tech Co., Ltd.
- Decided: Apr 14, 2026 after 242 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 K050622 (2005). 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)
- K223239: 8ch Wrist Coil, Shenzhen RF Tech Co., Ltd. (2022) Summary page 5.

## Indications for use
The Wrist Coil by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The Wrist Coil is designed to be use with GEHC 1.5T MRI systems to produce diagnostic images of the wrists and fingers that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K252587
Methodology: https://510kreport.com/methodology