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

K250440 · Brainlab AG · Radiology device

Jun 2025

Decision

123d

Days

Class 2

Risk

K250440 is an FDA 510(k) clearance for the RT Elements (4.5). This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on June 17, 2025, 123 days after receiving the submission on February 14, 2025.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.

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