Cleared Traditional

SIGNA? Sprint Select

K253779 · Ge Medical Systems, LLC · Radiology
Feb 2026
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K253779 is an FDA 510(k) clearance for the SIGNA? Sprint Select, 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 February 5, 2026, 71 days after receiving the submission on November 26, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K253779 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2025
Decision Date February 05, 2026
Days to Decision 71 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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