# K222259: NEONA 1.5T MRI System

- Pathway: 510(k) (Abbreviated)
- Applicant: Time Medical Limited
- Decided: Feb 21, 2023 after 208 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: 17 generations back to K971684 (1997). 34 ancestors in all.
No later device cites it as a predicate yet.
5 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183621: EMMA 1.5T MRI System, Time Medical Limited (2019) Summary page 5.

## Indications for use
NEONA 1.5T MRI system is indicated for use as a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.

Source page: https://510kreport.com/device/K222259
Methodology: https://510kreport.com/methodology