# K232021: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Sep 1, 2023 after 56 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: 5 generations back to K954190 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212864: dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T, Philips Healthcare (Suzhou) Co., Ltd. (2021) Summary page 4.
- K162001: 1.5T and 3.0T 16 CH GE Shoulder Coils, Invivo Corporation (2016) Summary page 4.

## Most influential descendants
- K260519: Smart Fit TorsoCardiac 1.5T (2026), 0 descendants of its own

## Indications for use
The Smart Fit TorsoCardiac 1.5T coll is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the torso (including chest, abdomen, pelvis), head and neck and heart that can be interpreted by a trained physician. The Smart Fit Shoulder 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the Shoulder that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K232021
Methodology: https://510kreport.com/methodology