Cleared Traditional

Liver Suite

K211180 · GE Medical Systems SCS · Radiology
May 2022
Decision
377d
Days
Class 2
Risk

About This 510(k) Submission

K211180 is an FDA 510(k) clearance for the Liver Suite, 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 May 2, 2022, 377 days after receiving the submission on April 20, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K211180 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2021
Decision Date May 02, 2022
Days to Decision 377 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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