# K231085: 1.5T HD T/R Knee Array (10-F34127)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen RF Tech Co., Ltd.
- Decided: Aug 18, 2023 after 123 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 K032633 (2003). 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)
- K223225: 8ch T/R Knee Coil, Shenzhen RF Tech Co., Ltd. (2023) Summary page 4.

## Indications for use
The Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd. is transmit/receive coil and is designed for use as general purpose coil. The Knee Coil is designed to be use with GEHC 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K231085
Methodology: https://510kreport.com/methodology