# K223523: Sonic DL

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems,Llc (Ge Healthcare)
- Decided: May 30, 2023 after 188 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)
- K213668: SIGNA Hero, Ge Healthcare (Ge Medical Systems, LLC) (2022) Summary page 4.

## Most influential descendants
- K243667: Sonic DL (2025), 0 descendants of its own

## Indications for use
Sonic DL is a Deep Learning based image reconstruction technique that is available for use on GE Healthcare 1.5T and 3.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for cardiac imaging, and for patients of all ages.

Source page: https://510kreport.com/device/K223523
Methodology: https://510kreport.com/methodology