Devices · Brainlab AG

RT Elements (4.5); (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

Brainlab AG is listed for RT Elements (4.5); (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). The FDA list gives June 17, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MUJ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250440

Official FDA database record

Date of final decision

June 17, 2025

Company on the FDA list

Brainlab AG

Lead panel

Radiology

Primary product code

MUJ

openFDA device name for the code

System, Planning, Radiation Therapy Treatment

Device class

2

Regulation number

892.5050

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary