# K091047: Neonate Array Coils

- Pathway: 510(k) (Traditional)
- Applicant: Lmt Medical Systems GmbH
- Decided: Aug 18, 2010 after 492 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: 2 generations back to K934396 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023929: Magnetic Resonance Diagnostic Device, Advanced Imaging Research, Inc. (2003) Summary page 1.

## Most influential descendants
- K171515: NHAC 16 (2017), 0 descendants of its own

## Indications for use
Used in a MR Scanner or used in the LMVT nomag IC incubator and a MR Scanner, the Neonate Array Coils (receive only) are indicated for use as a diagnostic imaging device to provide transversal, sagittal, coronal and oblique images of the internal structures of the head (Neonate Head Array Coil) and spine, torso (Neonate Body Array Coil). When interpreted by a trained physician, these images provide information that can be useful in the determination of a diagnosis. The excited nucleus is 1H (Proton). The signal received by the coils is dependent upon the MRI parameters (T1 or spin-lattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity and chemical shift). The Neonate Array coils are compatible to Siemens and Philips MRTs with 1.5T or 3.0T.

Source page: https://510kreport.com/device/K091047
Methodology: https://510kreport.com/methodology