Cleared Traditional

SIGNA MAGNUS

K241242 · Ge Medical Systems, LLC · Radiology
Oct 2024
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K241242 is an FDA 510(k) clearance for the SIGNA MAGNUS, 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 October 17, 2024, 167 days after receiving the submission on May 3, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K241242 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2024
Decision Date October 17, 2024
Days to Decision 167 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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