Cleared Traditional

Deep Learning Image Reconstruction

K213999 · Ge Medical Systems, LLC · Radiology
Feb 2022
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K213999 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 February 18, 2022, 59 days after receiving the submission on December 21, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K213999 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2021
Decision Date February 18, 2022
Days to Decision 59 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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