# K183621: EMMA 1.5T MRI System

- Pathway: 510(k) (Abbreviated)
- Applicant: Time Medical Limited
- Decided: Feb 22, 2019 after 58 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: 16 generations back to K971684 (1997). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161567: SIGNA Voyager, GE Healthcare (2016) Summary page 4.

## Most influential descendants
- K222259: NEONA 1.5T MRI System (2023), 0 descendants of its own

## Indications for use
The EMMA 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/K183621
Methodology: https://510kreport.com/methodology