Cleared Traditional

K234068 - ART-Plan (v.2.2.0)

K234068 is an FDA 510(k) clearance for ART-Plan (v.2.2.0), manufactured by Therapanacea Sas. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K234068 · Therapanacea Sas · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2024
Decision
122d
Days
Class 2
Risk

K234068 is an FDA 510(k) clearance for the ART-Plan (v.2.2.0). Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Therapanacea Sas (Paris, FR). The FDA issued a Cleared decision on April 22, 2024 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Therapanacea Sas devices

FDA 510(k) Submission Details - K234068

510(k) Number K234068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date April 22, 2024
Days to Decision 122 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 107d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 144
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K234068.
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K232400 · Varian Medical Systems · Sep 2023