Brainlab AG
FDA 510(k) medical device clearances.
Top product codes for Brainlab AG
Recent clearances by Brainlab AG
1–100 of 135- K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- K252562 — Spine & Trauma Navigation Instruments
- K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
- K243142 — Cranial 4Pi Immobilization
- 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
- 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)
- K242569 — Mixed Reality Spine Navigation
- 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
- K240431 — ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
- K240701 — Drill Guide; Drill Bit; Spine & Trauma Navigation
- K232759 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- K234047 — Automatic Registration
- K223864 — Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
- K223553 — Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
- K223288 — Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
- 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)
- K231052 — ExacTrac Dynamic 1.1.2
- K223734 — ENT EM
- K223552 — Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
- K223279 — RT Elements (4.0)
- K222966 — Cirq Arm System (2.0);Alignment System Spine
- K213989 — Cranial EM System
- K221618 — Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
- K220652 — Knee 3
- K220338 — ExacTrac Dynamic
- K213930 — Brainlab Elements Guide XT, Guide 3.0
- 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
- K212420 — Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
- 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
- K211544 — Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
- K211939 — ExacTrac Dynamic
- K203681 — RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
- K203679 — Automatic Registration
- K201752 — Disposable Pre-calibrated Suction
- K202320 — CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System
- K203173 — ExacTrac Dynamic
- 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
- K202050 — Cranial 4Pi Immobilization
- K201276 — ExacTrac Dynamic
- K193307 — HIP7
- K191014 — Elements Viewer
- K190250 — Microscope Navigation
- K183605 — Spine & Trauma Navigation
- K191285 — Spine & Trauma Navigation
- K190042 — Brainlab Elements Image Fusion Angio
- K190664 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
- K172820 — Microscope Navigation Software
- K170816 — Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
- K170750 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
- K153653 — DICOM Viewer
- K142108 — RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
- K141199 — QUENTRY DOSE REVIEW
- K132763 — ADVANCED VIEWER
- K122225 — STERILE RADIOLUCENT SKULL PINS
- K122011 — NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
- K122451 — EXACTRAC VERO
- K120789 — EXACTRAC X-RAY X-RAY
- K120520 — EXACTRAC ROBOTICS NOVALIS ROBOTICS
- K113732 — IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
- K110021 — DASH HIP
- K110204 — BRAINLAB TRAUMA
- K101627 — IPLAN
- K102251 — DASH KNEE
- K102990 — BRAINLAB KNEE
- K103246 — IPLAN RT
- K100038 — DISPOSABLE REFLECTIVE MARKER SPHERES
- K093118 — BRAINLAB KNEE ARTHROSCOPY
- K092467 — VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
- K093117 — DIGITAL LIGHTBOX
- K082060 — CRANIAL IMAGE GUIDED SURGERY SYSTEM
- K083483 — BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
- K083310 — SPINE & TRAUMA ICT
- K073615 — BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
- K080886 — IPLAN RT IMAGE
- K080888 — MODEIFICATION TO IPLAN RT DOSE
- K080678 — UNI-KNEE 2.0
- K080608 — DIGITAL LIGHTBOX
- K073018 — STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT
- K072506 — EXACTRAC 5.5
- K072046 — EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM
- K072716 — VECTOR VISION HIP
- K072573 — VECTORVISION HIP AND HIP SR
- K070556 — BRAINSUITE NET
- K070106 — VV FLUORO 3D
- K062358 — MODIFICATION TO VECTORVISION TRAUMA
- K063028 — VECTORVISION HIP SR
- K062086 — NAVIVISION
- K060727 — VECTORVISION HIP
- K053584 — IPLAN RT DOSE
- K053159 — VECTORVISION SPINE
- K053164 — IPLAN FLOW
- K060468 — VECTORVISION HIP
- K052966 — CI KNEE, CI MI TKR
- K053127 — IPLAN
- K053500 — FRAMELESS RADIOSURGERY COMPONENTS
- K052213 — NAVIGATION SW HIP 3.1 ON CI
- K052220 — IPLAN RT FIBERTRACKING
- K042543 — IPLAN! DIGITAL TEMPLATING
- K042721 — KOLIBRI SPINE
- K042513 — VECTORVISION OSTEOTOMY
Data sourced from openFDA. This site is unofficial and independent of the FDA.