AIR Recon DL

K252379

Ge Medical Systems, LLC · cleared 2025-12-23 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typesimd

source quote (p.5)

“AIR Recon DL is an optional feature that is integrated into the MR system software and activated through purchasable software option keys.”

Algorithmdeep learning-based reconstruction technique

source quote (p.5)

“It is a deep learning-based reconstruction technique that removes noise and ringing (truncation) artifacts from MR images.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (3)

Reader study (MRMC)

n=34 cases

endpoints: diagnostic quality of images; overall exceptional image quality across all organ systems

Prospective clinical

n=6 patients

endpoints: repeatability of AIR Recon DL with Phase Correction for ADC measurement; coefficient of variability for the ADC values

Standalone

n=4 scans

endpoints: ADC accuracy; low contrast detectability

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

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).