Cleared Traditional

AIR Recon DL

K252379 · Ge Medical Systems, LLC · Radiology
Dec 2025
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K252379 is an FDA 510(k) clearance for the AIR Recon DL, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on December 23, 2025, 146 days after receiving the submission on July 30, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K252379 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2025
Decision Date December 23, 2025
Days to Decision 146 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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