# K170978: Embrace Neonatal MRI System

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Imaging, Ltd.
- Decided: Jul 19, 2017 after 107 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: 4 generations back to K001773 (2000). 4 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160185: Wrist 3, Aspect Imaging, Ltd. (2016) Summary page 4.

## Most influential descendants
- K192002: Lucy Point-of-Care Magnetic Resonance Imaging Device (2020), 13 descendants of its own
- K201722: Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (2020), 10 descendants of its own
- K221923: Swoop Portable MR Imaging System (2022), 8 descendants of its own
- K223247: Swoop Portable MR Imaging System (2022), 7 descendants of its own
- K230208: Swoop® Portable MR Imaging System™ (2023), 6 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 displays 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/K170978
Methodology: https://510kreport.com/methodology