Medical Device Manufacturer · DE , Heimstetten

Brainlab AG

135 submissions · 135 cleared · Since 1996
135
Total
135
Cleared
0
Denied

Brainlab AG — FDA 510(k) Submissions

Brainlab AG has submitted 135 FDA 510(k) premarket notifications since 1996, of which 135 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Neurological Stereotaxic Instrument, Accelerator, Linear, Medical, Orthopedic Stereotaxic Instrument, System, Image Processing, Radiological, System, Planning, Radiation Therapy Treatment . Use the specialty filter in the sidebar to narrow results.

135 devices
1–25 of 135
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
K252476 · LLZ System, Image Processing,... · Radiology
Oct 2025 70d
Spine & Trauma Navigation Instruments
K252562 · OLO Orthopedic Stereotaxic... · Orthopedic
Sep 2025 29d
Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
K243432 · OWB Interventional... · Radiology
Jul 2025 259d
Cranial 4Pi Immobilization
K243142 · IYE Accelerator, Linear, Medical · Radiology
Jun 2025 266d
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 · MUJ System, Planning,... · Radiology
Jun 2025 123d
Brainlab 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)
K243633 · QIH Automated Radiological... · Radiology
Jun 2025 200d
Mixed Reality Spine Navigation
K242569 · SBF Orthopedic Augmented Reality · Orthopedic
May 2025 261d
Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
K243698 · HAW Neurological Stereotaxic... · Neurology
Jan 2025 60d
ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
K240431 · IYE Accelerator, Linear, Medical · Radiology
Jul 2024 161d
Drill Guide; Drill Bit; Spine & Trauma Navigation
K240701 · OLO Orthopedic Stereotaxic... · Orthopedic
May 2024 70d
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
K232759 · LLZ System, Image Processing,... · Radiology
May 2024 256d
Automatic Registration
K234047 · OLO Orthopedic Stereotaxic... · Orthopedic
Mar 2024 90d
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
K223864 · HAW Neurological Stereotaxic... · Neurology
Sep 2023 260d
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
K223553 · OLO Orthopedic Stereotaxic... · Orthopedic
Aug 2023 250d
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
K223288 · HAW Neurological Stereotaxic... · Neurology
Jul 2023 269d
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
K223106 · QIH Automated Radiological... · Radiology
Jul 2023 287d
ExacTrac Dynamic 1.1.2
K231052 · IYE Accelerator, Linear, Medical · Radiology
May 2023 28d
ENT EM
K223734 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Apr 2023 135d
Brainlab Elements ? Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
K223552 · HAW Neurological Stereotaxic... · Neurology
Apr 2023 145d
RT Elements (4.0)
K223279 · MUJ System, Planning,... · Radiology
Mar 2023 141d
Cirq Arm System (2.0);Alignment System Spine
K222966 · OLO Orthopedic Stereotaxic... · Orthopedic
Oct 2022 30d
Cranial EM System
K213989 · HAW Neurological Stereotaxic... · Neurology
Sep 2022 262d
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
K221618 · OLO Orthopedic Stereotaxic... · Orthopedic
Aug 2022 88d
Knee 3
K220652 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2022 88d
ExacTrac Dynamic
K220338 · IYE Accelerator, Linear, Medical · Radiology
Apr 2022 81d

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