# K222325: 8ch Wrist Coil

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation (Business Trade Name: Philips)
- Decided: Aug 31, 2022 after 29 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 K050622 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050622: HRW-63-8 Wrist Array Coil; HRW-127-8 Wrist Array Coil, Mri Devices Corporation (2005) Summary page 4.

## Most influential descendants
- K243033: dS Wrist coil 8ch 1.5T (2024), 0 descendants of its own

## Indications for use
The 8ch Wrist Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance scanner to produce diagnostic images of the wrist anatomy that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K222325
Methodology: https://510kreport.com/methodology