Cleared Traditional

K250440 - RT Elements (4.5) (FDA 510(k) Clearance)

Also includes:
(Elements) Multiple Brain Mets SRS (Elements) Cranial SRS (Elements) Spine SRS (Elements) Cranial SRS w/ Cones (Elements) RT Planning Platform (Elements) Dose Review (Elements) Retreatment Review Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT Elements AI Tumor Segmentation RT Elements SmartBrush [Angio, Spine] RT Elements Object Management RT

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

K250440 · Brainlab AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
123d
Days
Class 2
Risk

K250440 is an FDA 510(k) clearance for the RT Elements (4.5). 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 June 17, 2025 after a review of 123 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

Submission Details

510(k) Number K250440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2025
Decision Date June 17, 2025
Days to Decision 123 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
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 251
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K250440.
syngo.via RT Image Suite VC10
K252304 · Varian Medical Systems, Inc. · Mar 2026
Monaco RTP System (6.3)
K252002 · Elekta Solutions AB · Feb 2026
TrueFit Bolus
K260308 · Adaptiiv Medical Technologies, Inc. · Feb 2026
ART-Plan+ (v3.1.0)
K253091 · Therapanacea Sas · Dec 2025
RayStation (2024A SP3)
K252109 · RaySearch Laboratories AB (PUBL) · Dec 2025
ClearCalc Model RADCA V2.6
K252863 · Radformation, Inc. · Dec 2025