# K243667: Sonic DL

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jun 5, 2025 after 190 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)
- K223523: Sonic DL, Ge Medical Systems,Llc (Ge Healthcare) (2023) Summary page 5.

## Indications for use
Sonic DL is a Deep Learning based reconstruction technique that is available for use on GE HealthCare 1.5T, 3.0T, and 7.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for imaging patients of all ages. Sonic DL is not limited by anatomy and can be used for 2D cardiac cine imaging and 3D Cartesian imaging using fast spin echo and gradient echo sequences. Depending on the region of interest, contrast agents may be used.

Source page: https://510kreport.com/device/K243667
Methodology: https://510kreport.com/methodology