# K233600: Smart Fit Knee 3.0T

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Feb 5, 2024 after 88 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 K033567 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033567: Models HRK-63-8 PMS and HRK-127-8 Knee Array Coils, Mri Devices Corp. (2003) Summary page 4.

## Indications for use
The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K233600
Methodology: https://510kreport.com/methodology