# K253499: Ascent3T Neonatal Magnetic Resonance Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Eyas Medical Imaging, Inc.
- Decided: Jan 26, 2026 after 89 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.
No later device cites it as a predicate yet.
0 of 6 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 6.

## Indications for use
The Ascent3T Neonatal Magnetic Resonance Imaging System (Ascent3T) is a whole-body magnetic resonance scanner designed for neonates and infants. The system can produce cross-sectional images of the internal structure of the head, body or extremities in any orientation. Images produced by the Ascent3T show the spatial distribution of protons exhibiting magnetic resonance. Images produced by the Ascent3T, when interpreted by a trained physician, may provide information useful in diagnosis. The Ascent3T Neonatal Magnetic Resonance Imaging System is suitable for neonates and infants weighing up to 9kg (19.8 lbs).

Source page: https://510kreport.com/device/K253499
Methodology: https://510kreport.com/methodology