# K031095: Sense Body Coil

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jun 20, 2003 after 74 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: 3 generations back to K954190 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984588: Phased Array Flexible Cardiac Coil, Philips Medical Systems (Cleveland), Inc. (1999) Summary page 2.

## Indications for use
The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system. The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Abdominal, pelvic and thoracic regions Nuclei Excited: Hydrogen.

Source page: https://510kreport.com/device/K031095
Methodology: https://510kreport.com/methodology