Cleared Traditional

SIGNA? Sprint

K251399 · Ge Medical Systems, LLC · Radiology
Sep 2025
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K251399 is an FDA 510(k) clearance for the SIGNA? Sprint, 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 September 11, 2025, 128 days after receiving the submission on May 6, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K251399 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2025
Decision Date September 11, 2025
Days to Decision 128 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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