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

All identifiers (2)

Aletia (canonical)ALT-001086

FDA 510(k) · US (primary)K250440

Overview

Accountability Tier

Tier 2

Regulatory Registrations

🌐

FDA

ID: K250440

510k

Lifecycle Signals

Last Automated Sync

Mar 2026

Last Clinical Review

Not reviewed

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