# K261758: Embrace Vision Neonatal MRI System

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Imaging, Ltd.
- Decided: Sep 16, 2026 after 111 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: 6 generations back to K001773 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K254277: Embrace Neonatal MRI System, Aspect Imaging, Ltd. (2026) Summary page 5.

## Indications for use
The Embrace Vision 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/K261758
Methodology: https://510kreport.com/methodology