# K243033: dS Wrist coil 8ch 1.5T

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Oct 18, 2024 after 21 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)
- K222325: 8ch Wrist Coil, Invivo Corporation (Business Trade Name: Philips) (2022) Summary page 5.

## Indications for use
The dS Wrist Coil 8ch 1.5T is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of the wrist that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K243033
Methodology: https://510kreport.com/methodology