Cleared Special

SIGNA 7.0T

K211118 · Ge Medical Systems, LLC · Radiology
May 2021
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K211118 is an FDA 510(k) clearance for the SIGNA 7.0T, 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 May 13, 2021, 28 days after receiving the submission on April 15, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K211118 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2021
Decision Date May 13, 2021
Days to Decision 28 days
Submission Type Special
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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