# K260519: Smart Fit TorsoCardiac 1.5T

- Pathway: 510(k) (Special)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Mar 20, 2026 after 31 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: 6 generations back to K954190 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232021: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T, Philips Healthcare (Suzhou) Co., Ltd. (2023) Summary page 5.

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

Source page: https://510kreport.com/device/K260519
Methodology: https://510kreport.com/methodology