Company profile

Brainlab AG

Brainlab AG has 9 AI-enabled medical devices on the FDA list. The first decision was on April 19, 2023 and the most recent on June 17, 2025 (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). Its most common review panel is Neurology (6 devices).

9AI devices

2023First decision

2025Latest decision

2Specialties

Per year

202320242025

Brainlab AG AI devices per year: 2023 6, 2024 1, 2025 2

By specialty

Neurology6
Radiology3

Timeline

June 17, 2025 · 510(k) K250440RT 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 · Radiology · MUJ
June 13, 2025 · 510(k) K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) · Radiology · QIH
March 20, 2024 · 510(k) K234047Automatic Registration · Neurology · OLO
September 9, 2023 · 510(k) K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial · Neurology · HAW
August 2, 2023 · 510(k) K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine · Neurology · OLO
July 21, 2023 · 510(k) K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI · Neurology · HAW
July 14, 2023 · 510(k) K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) · Radiology · QIH
April 27, 2023 · 510(k) K223734ENT EM · Neurology · PGW
April 19, 2023 · 510(k) K223552Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial · Neurology · HAW