Cleared Traditional

Deep Learning Image Reconstruction

K183202 · Ge Medical Systems, LLC · Radiology
Apr 2019
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K183202 is an FDA 510(k) clearance for the Deep Learning Image Reconstruction, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on April 12, 2019, 144 days after receiving the submission on November 19, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K183202 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2018
Decision Date April 12, 2019
Days to Decision 144 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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