# K254277: Embrace Neonatal MRI System

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Imaging, Ltd.
- Decided: Mar 13, 2026 after 73 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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: 5 generations back to K001773 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170978: Embrace Neonatal MRI System, Aspect Imaging, Ltd. (2017) Summary page 5.

## Most influential descendants
- K261758: Embrace Vision Neonatal MRI System (2026), 0 descendants of its own

## Indications for use
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that display the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K254277
Methodology: https://510kreport.com/methodology