Cleared Traditional

SIGNA Prime Elite

K250379 · Ge Medical Systems, LLC · Radiology
Mar 2025
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K250379 is an FDA 510(k) clearance for the SIGNA Prime Elite, 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 March 17, 2025, 34 days after receiving the submission on February 11, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K250379 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2025
Decision Date March 17, 2025
Days to Decision 34 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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