Brainlab AG FDA Approvals

0 new drug approvals and 34 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout510(k)Oct 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 16, 2025
Spine & Trauma Navigation Instruments510(k)Sep 12, 2025Neurology	Neurology	510(k)Substantially Equivalent (Special)	Sep 12, 2025
Vascular Navigation PAD 2.0; Navigation Software Vascular PAD510(k)Jul 22, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 22, 2025
Cranial 4Pi Immobilization510(k)Jun 23, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 23, 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 RT510(k)Jun 17, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 17, 2025
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)510(k)Jun 13, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 13, 2025
Mixed Reality Spine Navigation510(k)May 16, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	May 16, 2025
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 LITT510(k)Jan 28, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 28, 2025
ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface510(k)Jul 24, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 24, 2024
Drill Guide; Drill Bit; Spine & Trauma Navigation510(k)May 23, 2024Neurology	Neurology	510(k)Substantially Equivalent (Special)	May 23, 2024
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout510(k)May 21, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 21, 2024
Automatic Registration510(k)Mar 20, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 20, 2024
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial510(k)Sep 9, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 9, 2023
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine510(k)Aug 2, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 2, 2023
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI510(k)Jul 21, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 21, 2023
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)510(k)Jul 14, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 14, 2023
ExacTrac Dynamic 1.1.2510(k)May 11, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	May 11, 2023
ENT EM510(k)Apr 27, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 27, 2023
Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial510(k)Apr 19, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 19, 2023
RT Elements (4.0)510(k)Mar 14, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 14, 2023
Cirq Arm System (2.0);Alignment System Spine510(k)Oct 27, 2022Neurology	Neurology	510(k)Substantially Equivalent (Special)	Oct 27, 2022
Cranial EM System510(k)Sep 8, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 8, 2022
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System510(k)Aug 30, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 30, 2022
Knee 3510(k)Jun 3, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 3, 2022
ExacTrac Dynamic510(k)Apr 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 29, 2022
Brainlab Elements Guide XT, Guide 3.0510(k)Apr 19, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 19, 2022
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning510(k)Apr 13, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 13, 2022
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio510(k)Dec 16, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 16, 2021
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System510(k)Nov 12, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 12, 2021
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization510(k)Nov 3, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 3, 2021
ExacTrac Dynamic510(k)Jul 22, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 22, 2021
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review510(k)Apr 9, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 9, 2021
Automatic Registration510(k)Mar 18, 2021Neurology	Neurology	510(k)Substantially Equivalent (Special)	Mar 18, 2021
Disposable Pre-calibrated Suction510(k)Jan 29, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 29, 2021

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