# K242573: NIDO Baby Magnetic Resonance Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Lici Medical Device Co., Ltd.
- Decided: Dec 23, 2024 after 116 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)
- K170978: Embrace Neonatal MRI System, Aspect Imaging, Ltd. (2017) Summary page 5.
- K192002: Lucy Point-of-Care Magnetic Resonance Imaging Device, Hyperfine Research, Inc. (2020) Summary page 5.

## Indications for use
The NIDO Baby Magnetic Resonance Imaging 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 or infant head. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The NIDO Baby Magnetic Resonance Imaging System is applicable to neonatal or infant head with circumference of up to 50 cm and weight up to 15Kg.

Source page: https://510kreport.com/device/K242573
Methodology: https://510kreport.com/methodology