Radiology · 510(k) · 2025
AIR Recon DL
Ge Medical Systems, LLC. Cleared by FDA on 23 December 2025 under submission K252379, product code LNH (system, nuclear magnetic resonance imaging). What FDA's record says, in FDA's words.
Device record · K252379
- Device. AIR Recon DLDEVICE
- Company. Ge Medical Systems, LLCCOMPANY
- Decision. 23 December 2025, 510(k), substantially equivalent (traditional review); received 30 July 2025DECISION
- Panel. RadiologyPANEL
- Product code. LNH, System, Nuclear Magnetic Resonance ImagingCODE
- Regulation. 21 CFR 892.1000, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K252379Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? lAIR Recon DL Please provide your Indications for Use below. AIR Recon DL is a deep learning based reconstruction technique that is available for use on GE HealthCare 1.5T, 3.0T, and 7.OT 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. I Please select the types of uses (select one or both, as ZPrescription Use (Part 21 CFR 801 Subpart D) [ Over-The-Counter Use (21 CFR 801 Subpart C)applicable). AIR Recon DL Traditional 510(k) Premarket Notification 510(k) Summary In accordance with 21 CFR 807.92, the following summary of information is provided: Date December 19, 2025 Submitter GE Medical Systems, LLC 3200 N. Grandview Blvd. Waukesha, WI 53188 Primary Contact Andrew Turner Regulatory Affairs Leader 484-630-7798 [email protected] Secondary Contact Glen Sabin Regulatory Affairs Director 262-894-4968 [email protected] Device Trade Name AIR Recon DL Common/Usual Name MR System
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedMRI
- Mentionstriage or notification
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4,787 reports filed against devices carrying product code LNH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
29 September 2026 · Malfunction · Achieva 1.5T Dstream · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000174
28 September 2026 · Malfunction · Achieva 1.5T · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000166
Philips received a report that the Quadrature Body Coil (QBC) seal on the front cover is coming loose. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is loose, it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000167
Philips received a report that the upper Quadrature Body Coil (QBC) seal has peeling off. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is peeled it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000168
Philips received a report that the Quadrature Body Coil (QBC) seal has come loose. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal comes loose it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000169
Philips received a report that the upper Quadrature Body Coil (QBC) seal has come loose This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is loose it is likely that this could lead to serious injury.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code LNH, in Radiology, from Ge Medical Systems, LLC, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.