Cleared Traditional

K223279 - RT Elements (4.0)

K223279 is an FDA 510(k) clearance for RT Elements (4.0), manufactured by Brainlab AG. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K223279 · Brainlab AG · Radiology device
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Mar 2023
Decision
141d
Days
Class 2
Risk

K223279 is an FDA 510(k) clearance for the RT Elements (4.0). Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on March 14, 2023 after a review of 141 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 Brainlab AG devices

FDA 510(k) Submission Details - K223279

510(k) Number K223279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2022
Decision Date March 14, 2023
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
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 207
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K223279.
Eclipse Treatment Planning System (v18.0)
K230557 · Varian Medical Systems, Inc. · May 2023
Radiation Planning Assistant (RPA)
K222728 · University of Texas, MD Anderson Cancer Center · May 2023
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Monaco RTP System
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K222803 · Oncospace, Inc. · Feb 2023
syngo.via RT Image Suite
K220783 · Siemens Medical Solutions USA, Inc. · Sep 2022