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Brainlab AG

FDA 510(k) & PMA Approved Devices — 50 products

Total Devices50
Categories10
Latest Approval2025-10-16
TypeNumberDevice NameCodeDate
510(k) K252476 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout LLZ 2025-10-16 View
510(k) K252562 Spine & Trauma Navigation Instruments OLO 2025-09-12 View
510(k) K243432 Vascular Navigation PAD 2.0; Navigation Software Vascular PAD OWB 2025-07-22 View
510(k) K243142 Cranial 4Pi Immobilization IYE 2025-06-23 View
510(k) K250440 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 MUJ 2025-06-17 View
510(k) K243633 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) QIH 2025-06-13 View
510(k) K242569 Mixed Reality Spine Navigation SBF 2025-05-16 View
510(k) K243698 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 HAW 2025-01-28 View
510(k) K240431 ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface IYE 2024-07-24 View
510(k) K240701 Drill Guide; Drill Bit; Spine & Trauma Navigation OLO 2024-05-23 View
510(k) K232759 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout LLZ 2024-05-21 View
510(k) K234047 Automatic Registration OLO 2024-03-20 View
510(k) K223864 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial HAW 2023-09-09 View
510(k) K223553 Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine OLO 2023-08-02 View
510(k) K223288 Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI HAW 2023-07-21 View
510(k) K223106 Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) QIH 2023-07-14 View
510(k) K231052 ExacTrac Dynamic 1.1.2 IYE 2023-05-11 View
510(k) K223734 ENT EM PGW 2023-04-27 View
510(k) K223552 Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial HAW 2023-04-19 View
510(k) K223279 RT Elements (4.0) MUJ 2023-03-14 View
510(k) K222966 Cirq Arm System (2.0);Alignment System Spine OLO 2022-10-27 View
510(k) K213989 Cranial EM System HAW 2022-09-08 View
510(k) K221618 Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System OLO 2022-08-30 View
510(k) K220652 Knee 3 OLO 2022-06-03 View
510(k) K220338 ExacTrac Dynamic IYE 2022-04-29 View
510(k) K213930 Brainlab Elements Guide XT, Guide 3.0 QQC 2022-04-19 View
510(k) K212245 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 Planning OLO 2022-04-13 View
510(k) K212420 Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio LLZ 2021-12-16 View
510(k) K210989 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 System HAW 2021-11-12 View
510(k) K211544 Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization HAW 2021-11-03 View
510(k) K211939 ExacTrac Dynamic IYE 2021-07-22 View
510(k) K203681 RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review MUJ 2021-04-09 View
510(k) K203679 Automatic Registration OLO 2021-03-18 View
510(k) K201752 Disposable Pre-calibrated Suction HAW 2021-01-29 View
510(k) K202320 CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System OLO 2020-12-23 View
510(k) K203173 ExacTrac Dynamic IYE 2020-11-12 View
510(k) K192703 Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update HAW 2020-10-08 View
510(k) K202050 Cranial 4Pi Immobilization IYE 2020-08-19 View
510(k) K201276 ExacTrac Dynamic IYE 2020-07-13 View
510(k) K193307 HIP7 OLO 2020-06-02 View
510(k) K191014 Elements Viewer LLZ 2020-01-23 View
510(k) K190250 Microscope Navigation HAW 2019-09-06 View
510(k) K183605 Spine & Trauma Navigation OLO 2019-08-29 View
510(k) K191285 Spine & Trauma Navigation OLO 2019-06-11 View
510(k) K190042 Brainlab Elements Image Fusion Angio LLZ 2019-04-25 View
510(k) K190664 RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review MUJ 2019-04-12 View
510(k) K172820 Microscope Navigation Software HAW 2018-03-01 View
510(k) K170816 Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM LLZ 2017-09-26 View
510(k) K170750 RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review MUJ 2017-08-24 View
510(k) K153653 DICOM Viewer LLZ 2016-04-13 View
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