# K213717: AIR Recon DL

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems,Llc (Ge Healthcare)
- Decided: Jun 8, 2022 after 196 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: 18 generations back to K971684 (1997). 35 ancestors in all.
2 later devices descend from it; 2 cite it directly.
5 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193282: SIGNA Premier, Ge Healthcare (Ge Medical Systems, LLC) (2020) Summary page 4.

## Most influential descendants
- K253808: AIR Recon DL (2026), 0 descendants of its own
- K252379: AIR Recon DL (2025), 0 descendants of its own

## Indications for use
AIR Recon 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. AIR Recon DL reduces noise and ringing (truncation artifacts) in MR images, which can be used to reduce scan time and improve image quality. AIR Recon DL is intended for use with all anatomies, and for patients of all ages. Depending on the anatomy of interest being imaged, contrast agents may be used.

Source page: https://510kreport.com/device/K213717
Methodology: https://510kreport.com/methodology