Cleared Traditional

Artemis, Artemis TPO, Artemis MX

K222222 · Eigen · Radiology
Oct 2023
Decision
444d
Days
Class 2
Risk

About This 510(k) Submission

K222222 is an FDA 510(k) clearance for the Artemis, Artemis TPO, Artemis MX, a Radiological Image Processing Software For Ablation Therapy Planning And Evaluation (Class II — Special Controls, product code QTZ), submitted by Eigen (Grass Valley, US). The FDA issued a Cleared decision on October 12, 2023, 444 days after receiving the submission on July 25, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K222222 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2022
Decision Date October 12, 2023
Days to Decision 444 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QTZ — Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Radiological Image Processing Tools For Planning, Monitoring, And Evaluating Ablation Therapy.