# K171515: NHAC 16

- Pathway: 510(k) (Special)
- Applicant: Lmt Medical Systems GmbH
- Decided: Jul 26, 2017 after 63 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 K934396 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091047: Neonate Array Coils, Lmt Medical Systems GmbH (2010) Summary page 4.

## Indications for use
The NHAC 16 is a local coil (receive only) and is intended to be used in conjunction with 1.5T or 3.0T magnetic resonance imaging (MRI) systems by Philips or Siemens and can be used in conjunction with the MR Diagnostics Incubator System nomag® IC. It provides MR images of the neonatal head, non-invasively and without the use of ionizing radiation.

Source page: https://510kreport.com/device/K171515
Methodology: https://510kreport.com/methodology