Cleared Traditional

GSI Viewer with GSI Fat Option

K180225 · GE Medical Systems SCS · Radiology
Apr 2018
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K180225 is an FDA 510(k) clearance for the GSI Viewer with GSI Fat Option, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on April 24, 2018, 88 days after receiving the submission on January 26, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K180225 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2018
Decision Date April 24, 2018
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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