Sonic DL
K223523GE Medical Systems,LLC (GE Healthcare) · cleared 2023-05-30 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Sonic DL is a new software feature intended for use with GE Healthcare MR systems. It consists of a deep learning based reconstruction algorithm that is applied to data from MR cardiac cine exams obtained using a highly accelerated acquisition technique. Sonic DL is an optional feature that is integrated into the MR system software and activated through a purchasable software option key.”
source quote (p.4)
“It consists of a deep learning based reconstruction algorithm that is applied to data from MR cardiac cine exams obtained using a highly accelerated acquisition technique.”
Validation studies (5)
Bench
sample size not stated
endpoints: Peak-Signal-to-Noise (PSNR); Root-Mean-Square Error (RMSE); Structural Similarity Index Measure (SSIM); Mean Absolute Error (MAE); in-plane sharpness; temporal sharpness
Reader study (MRMC)
n=57 patients · 7 site(s)
endpoints: left ventricular volumes; ejection fraction; cardiac output
Reader study (MRMC)
n=127 images · 7 site(s)
endpoints: blinded image quality assessments; diagnostic quality; reduction in scan time
Retrospective clinical
n=19 patients
endpoints: model accuracy; temporal sharpness evaluations
Retrospective clinical
n=10 patients
endpoints: functional measurements; image quality
Reported performance (2 observations)
source quote (p.6)
“The results showed that the inter-method variability (coefficient of variability comparing functional measurements taken with Sonic DL images versus measurements using the conventional ASSET Cine images) was smaller than the inter-observer intra-method variability for the conventional ASSET Cine images for all parameters, indicating that Sonic DL is suitable for performing functional cardiac measurements.”
source quote (p.7)
“Similar to the nonclinical testing using the digital phantom, model accuracy and temporal sharpness evaluations were conducted using in vivo cardiac cine images obtained from 19 health volunteers.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243667 (decision 2025-06-05) from GE Medical Systems, LLC for a matching device line ("Sonic DL") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243667
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98779
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98111
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).