Cleared Traditional

K222222 - Artemis, Artemis TPO, Artemis MX (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K222222 is an FDA 510(k) clearance for the Artemis, Artemis TPO, Artemis MX. Classified as Radiological Image Processing Software For Ablation Therapy Planning And Evaluation (product code QTZ), Class II - Special Controls.

Submitted by Eigen (Grass Valley, US). The FDA issued a Cleared decision on October 12, 2023 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

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Submission Details

510(k) Number K222222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
337d slower than avg
Panel avg: 107d · This submission: 444d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Radiological Image Processing Tools For Planning, Monitoring, And Evaluating Ablation Therapy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

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