Cleared Traditional

SIGNA 7.0T

K201615 · Ge Medical Systems, LLC · Radiology
Oct 2020
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K201615 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 October 15, 2020, 122 days after receiving the submission on June 15, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K201615 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2020
Decision Date October 15, 2020
Days to Decision 122 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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