# K110487: Flexible Cardiac Coil

- Pathway: 510(k) (Traditional)
- Applicant: Lbds Holding Company
- Decided: Apr 19, 2011 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1.5T MRI systems are intended for use as NMR devices that produce images that (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time TI, spin-spin relaxation time fl) 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 usefuil in the determination of a diagnosis. The Flexible Cardiac Coil is indicated for use with Philips lST MRI systems in the following anatomic regions and with the designated nuclei. Anatomic Regions: Heart and associated structures in the thoracic region. Nuclei Excited: Hydrogen

Source page: https://510kreport.com/device/K110487
Methodology: https://510kreport.com/methodology