| K-number | K252379 |
| Device name | AIR Recon DL |
| Applicant | Ge Medical Systems, LLC |
| Product code | LNH |
| Device class | Class II |
| Decision date | Dec 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1000 |
AIR Recon DL is a deep learning-based reconstruction software feature for GE HealthCare MR systems (1.5T, 3.0T, and 7.0T) that reduces noise and ringing artifacts in MR images. It is intended for use with all anatomies and patients of all ages to improve image quality and reduce scan time.
The proposed device adds a new Deep Learning Phase Correction (DLPC) model and PC Compatible AIR Recon DL (PC-ARDL) model for applications creating multiple intermediate images that are combined, such as Diffusion Weighted Imaging. These work together to provide more accurate phase correction and signal accuracy compared to the predicate device's earlier version.
Not stated in this summary.
The proposed AIR Recon DL is substantially equivalent to the predicate device (K213717) because both are deep learning-based reconstruction techniques for MR systems with the same intended use. Nonclinical and clinical testing demonstrated the new DLPC and PC-ARDL models provide adequate image quality without introducing new hazards or safety concerns beyond those associated with MR imaging generally, making it at least as safe and effective as the predicate.
View the full FDA submission: accessdata.fda.gov