AIR Recon DL

K213717

GE Medical Systems,LLC (GE Healthcare) · cleared 2022-06-08 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typesimd

source quote (p.5)

“AIR Recon DL is a software feature intended for use with GE Healthcare MR systems. It is a deep learning based reconstruction technique that removes noise and ringing (truncation) artifacts from MR images.”

Algorithmdeep learning based reconstruction technique

source quote (p.5)

“AIR Recon DL is a software feature intended for use with GE Healthcare MR systems. It is a deep learning based reconstruction technique that removes noise and ringing (truncation) artifacts from MR images. The predicate device used deep learning convolutional neural networks to remove noise and ringing from certain 2D Cartesian acquisitions. The proposed AIR Recon DL has been modified to be compatible with PROPELLER and selected 3D Cartesian acquisitions. Both the proposed AIR Recon DL and the predicate device use neural networks that have similar architecture, and were trained using similar methods and data.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: SNR; sharpness; low contrast detectability; Diffusion Coefficient (ADC) maps

Reader study (MRMC)

n=133 cases · 10 site(s)

endpoints: image quality in terms of apparent signal to noise ratio; sharpness; lesion conspicuity; radiologists preference; image quality for shorter scan times; accuracy of quantitative measurements such as contrast pharmacokinetics, lesion sizes, and brain volumetry results

Reported performance (1 observation)

accuracyas written: “accuracy of quantitative measurements”stated without value

source quote (p.7)

“The analysis showed strong agreement between measurements made using conventional and AIR Recon DL images.”

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

100

recalls in product code, 24mo

510

MAUDE reports in code, 12mo

+5%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K252379 (decision 2025-12-23) from Ge Medical Systems, LLC for a matching device line ("AIR Recon DL") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252379
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).