Cleared Traditional

K232479 - ART-Plan

K232479 is an FDA 510(k) clearance for ART-Plan, manufactured by Therapanacea. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K232479 · Therapanacea · Radiology device
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Dec 2023
Decision
128d
Days
Class 2
Risk

K232479 is an FDA 510(k) clearance for the ART-Plan. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Therapanacea (Paris, FR). The FDA issued a Cleared decision on December 22, 2023 after a review of 128 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.

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FDA 510(k) Submission Details - K232479

510(k) Number K232479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2023
Decision Date December 22, 2023
Days to Decision 128 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
21d slower than avg
Panel avg: 107d · This submission: 128d
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 K232479.
Radiance V5
K233236 · Gmv Soluciones Globales Internet S.A.U. · May 2024
syngo.via RT Image Suite
K232799 · Siemens Medical Solutions USA, Inc. · Apr 2024
ART-Plan (v.2.2.0)
K234068 · Therapanacea Sas · Apr 2024
Panther TPS
K231825 · Prowess, Inc. · Dec 2023
VariSeed (v10)
K232400 · Varian Medical Systems · Sep 2023
MOZI TPS
K223724 · Manteia Technologies Co., Ltd. · Jul 2023