Cleared Traditional

Sonic DL

K243667 · Ge Medical Systems, LLC · Radiology
Jun 2025
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K243667 is an FDA 510(k) clearance for the Sonic 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 June 5, 2025, 190 days after receiving the submission on November 27, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K243667 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2024
Decision Date June 05, 2025
Days to Decision 190 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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