BRAINLAB SE

FDA Device Registration & Listing · Munich Bavaria, DE · Registration 8043933

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8043933
FEI Number
3002619595
Entity Name
BRAINLAB SE
City/State/Country
Munich Bavaria, DE
Establishment Address
Olof-Palme-Strasse 9, Munich Bavaria 81829, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Brainlab SE (Owner Number: 9004547)
Owner / Operator Contact Address
Olof-Palme-Strasse 9, Munich, DE-BY 81829, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Microscope Navigation Microscope Tracking Array Microscope Adapter For Tracking Array (ZEISS) Microscope Adapter For Tracking Array (LEICA) 27 Touchdisplay Foreseeson MDSC-2226, MDSC-2232, MDSC-2242, MDSC-2324, MDSC-2326, MDSC-8231, MDSC-8255, MDSC-8258, MDSC-8527NXF M2, MDSC-8532NXF M2 Barco Display Alignment Software Spine Navigation Software Spine & Trauma Spine & Trauma Navigation Alignment System Spine Cirq Robotic Disposable Kinematic Unit Cirq Robotic Tracking Array Spine 10 Alignment Guide Tube Spine 2.4/10 DRILL BIT 3.2 MM DEPTH CONTROL 60-100 MM Alignment Guide Tube Spine 2.6/10 CIRQ ROBOTIC TRACKING ARRAY 10 Alignment Trocar Spine 3.2 DRILL BIT 4.5 MM DEPTH CONTROL 60-100 MM Cirq Arm System Kick 2 Navigation Station Cirq Robotic Depth Tracking Array black Cirq Robotic Depth Tracking Array beige Buzz Navigation (Ceiling-Mounted) Spine Navigation Curve Navigation Registration Fluoro 3D Alignment Trocar Spine 2.4 Cirq Robotic Instrument Holder Spine Curve Navigation 17700 Alignment Bone Anchor Cranial 2.1/3.8 DRILL BIT 4.5 MM DEPTH CONTROL 0–60 MM Alignment Trocar Spine 2.6 Alignment Trocar Spine 6/10 Alignment Guide Tube Spine 3.2/10 Alignment Depth Control Spine Automatic Registration Skull Reference Screwdriver Blade Hex Screwdriver Ball-End (2.5 mm) Skull Reference Screwdriver Handle DOUBLE OPEN-END WRENCH (10 X 14 MM) Hex Screwdriver T-Handle (2.5 mm) Elements Segmentation CMF Elements Lead Localization Elements Segmentation Basal Ganglia Elements Segmentation Head & Neck Elements Segmentation Thoracic & Spine Elements Segmentation Spine Elements SmartBrush Elements Segmentation Cranial Elements Trajectory Planning Elements Segmentation Pelvic Elements Anatomical Mapping Elements Object Manipulation Elements SmartBrush Angio Elements SmartBrush Spine SRS Elements Fibertracking RT Elements Fibertracking iPlan iPlan CMF Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization Cranial 4Pi Immobilization CRANIAL 4PI HEADREST INLAY H&N 2PCS CRANIAL 4PI STEREOTACTIC MASK (5PCS.) CRANIAL 4PI HEADREST LOW-NECK CRANIAL 4PI HEADREST INLAY OPENFACE 2PCS CRANIAL 4PI HEADREST STANDARD CRANIAL 4PI OPEN FACE MASK (5PCS.) CRANIAL 4PI HEADREST INLAY STANDARD 2PCS CRANIAL 4PI BASIC MASK (5 PCS.) CRANIAL 4PI EXTENDED MASK (5 PCS.) CRANIAL 4PI HEADREST INLAY OPENFACE CRANIAL 4PI HEADREST INLAY H&N Elements Image Fusion Angio Brainlab Elements Image Fusion Angio Image Fusion Angio ARTPlan Curve Navigation 17700 ENT EM Skull Reference Base EM EM Registration Pointer EM Instrument Tracker Curve Navigation Kick 2 Navigation Station EM EM Pointer EM Short Pointer EM Patient Reference Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mm Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw ARIETTA Precision Spine & Trauma Navigation Drill Guide Depth Control (60-100 mm) Drill Bit Drill Guide Tube (3.2 mm) Drill Guide Handle Compact Drill Guide Array Drill Guide Depth Control (0-60 mm) Drill Guide Trocar Insert (2.6) Drill Guide Trocar Insert (2) Drill Guide Tube (2 mm) DRILL BIT 2 MM DEPTH CONTROL 0–60 MM DRILL BIT 3.2 MM DEPTH CONTROL 60-100 MM Drill Guide Trocar Insert (2.4) DRILL BIT 4.5 MM DEPTH CONTROL 0–60 MM Drill Guide Drill Guide Trocar Insert (4.5) DRILL BIT 4.5 MM DEPTH CONTROL 60-100 MM Drill Guide Tube (4.5 mm) Drill Guide Tube (2.4 mm) Sterilization Tray Drill Guide Drill Guide Tube (2.6 mm) Drill Guide Trocar Insert (3.2) Drill Guide Handle TraumaCAD Cirq Robotic Alignment Module Spinal Cirq CIRQ Robotic Alignment Cranial and Spine System Cirq Robotic Alignment System Cirq Robotic Alignment Cranial And Spine Cirq Robotic Disposable Kinematic Unit Mixed Reality Viewer Viewer 5.4 Elements Viewer Elements Viewer Smart Layout Double Open-End Wrench (10 X 14 MM) DISPOSABLE STERILE RADIOLUCENT SKULL PINS ExacTrac Dynamic Surface ExacTrac Dynamic 2 ExacTrac® X-Ray Exactrac Automatic Registration Kick 2 Navigation Station EM Cranial Navigation Navigation Software Cranial Navigation Software Craniofacial DRAPELINK REF ADAPTER AUTO-REG IMRI EM Patient Reference Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mm EM Short Pointer Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw Ultrasound Navigation Buzz Navigation (Ceiling Mounted) Curve Navigation Curve Navigation 17700 EM Instrument Tracker EM Registration Pointer Automatic Registration iMRI Microscope Navigation Cranial EM System Kick 2 Navigation Station Skull Reference Base EM EM Stylet EM Pointer AUTO-REG MATRIX IMRI Nexxis OR MobiCT-32 AIRO Mobile CT System MRI LINE MARKER Reinforcement-Arm C-ARM ADAPTER GE OEC 3D RIGHT INSTRUMENT ADAPTER CLAMP STARLINK SOFTGRIP SIZE XL Mechatronic VarioGuide Mechatronic Arm Surgical Base System - SBS Curve Navigation 17700 CIRQ Spine and Trauma 3D Navigation Kick 2 EM Navigation Station INSTRUMENT ADAPTER CLAMP STARLINK SIZE S C-ARM REFERENCE UNIT RIGHT CHISEL LONG FOR OPEN SURGERY Drill Guide Depth Control REFLECTIVE DISKS FLUORO KIT REV2-21 PCS PATIENT REFERENCE ARRAY T-GEOMETRY X-PRESS INSTRUMENT TRACKING ARRAY STARLINK SIZE M Drill Guide Depth Control (200mm) INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL Tissue Protection Sleeve Grip PATIENT REFERENCE ARRAY Y-GEOMETRY X-PRESS INSTRUMENT TRACKING ARRAY S&T (SIZE ML) INSTRUMENT TRACKING ARRAY STARLINK SIZE XL ADAPTER LONG FOR PATIENT REFERENCE CLAMP HANDLE UNIVERSAL FOR OPEN SURGERY INSTRUMENT ADAPTER STARLINK EXTENSION 50 MM C-ARM ADAPTER SIEMENS CIOS SPIN RIGHT INSTRUMENT TRACKING ARRAY S&T 3-MARKER INSTRUMENT ADAPTER CLAMP STARLINK SOFTGRIP SIZE L CHISEL SHORT FOR OPEN SURGERY BONE FIXATOR 2-PIN X-PRESS ADAPTER FOR SURGICAL MOTOR SYSTEM INSTRUMENT ADAPTER CLAMP STARLINK SIZE M AWL (4 MM) FOR OPEN SURGERY DISP FIXATION PIN 4 x 125 MM (10 PCS) C-ARM REFERENCE UNIT LEFT Cirq Instrument Holder Module AWL (3 MM) FOR OPEN SURGERY C-ARM ADAPTER ZIEHM RFD 3D RIGHT Drill Guide Compact Handle 4 Markers INSTRUMENT TRACKING ARRAY STARLINK SIZE L INSTRUMENT TRACKING ARRAY S&T (SIZE L) RADIOLUCENT DRAPELINK INTERFACE FOR CALIBRATION PHANTOM INTRAOPERATIVE CT C-ARM ADAPTER ZIEHM RFD 3D LEFT CALIBRATION PHANTOM ICT INSTRUMENT TRACKING ARRAY STARLINK SIZE ML C-ARM ADAPTER GE OEC 3D LEFT PROBE STRAIGHT (3.5 MM) FOR OPEN SURGERY INSTRUMENT ADAPTER STARLINK ANGLED 45° Cirq Instrument Holder Spinal Drilling Drill Guide Depth Control Insertable Guide Tube Pedicle Access Needle (1.8 mm) INSTRUMENT TRACKING ARRAY S&T 4-MARKER Drill Guide Handle 4-Marker PROBE STRAIGHT (4.5 MM) FOR OPEN SURGERY Instrument Calibration Matrix PROBE CURVED (4.5 MM) FOR OPEN SURGERY HANDLE GEARSHIFT FOR OPEN SURGERY Drill Guide Handle INSTRUMENT ADAPTER CLAMP STARLINK SIZE L Disposable Trocar Insert Pedicle Access Needle (5 PCS) C-ARM ADAPTER SIEMENS CIOS SPIN LEFT ADHESIVE REFLECTIVE FLAT MARKERS (10PCS) Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio AIRO Mobile CT System Buzz O.R Compute Quentry Gateway quentry.com; Quentry Quentry Mobile Viewer; Quentry Mobile Quentry Desktop Quentry Basic Viewer Patient Browser Dicom Proxy Buzz in-wall Buzz on-wall Buzz Buzz Compact Buzz Virtual App Buzz Virtual quentry.com NOVALIS KNOWLEDGE BASE NOVALIS KNOWLEDGE STUDY Quip Eye Wall Touch Screen Brainlab Elements Image Fusion Angio Brainlab Elements Fibertracking Brainlab Elements BOLD MRI Mapping Brainlab Elements 6 Brainlab Elements Contouring Brainlab Elements Image Fusion Patient Selection Buzz 3rd Party: NDS Data Screen WS-343DV-BEGNT WS-343DV-BEG BrainLAB Mask System BrainLAB H & N Treatment System Mask System Head & Neck Treatment System Patient Mask Set (5pcs) ExacTrac Dynamic 1.1.2 RT Elements 4.5 Elements AI Tumor Segmentation RT Elements SmartBrush [Angio, Spine] RT (Elements) Retreatment Review Elements Object Management RT (Elements) RT Planning Platform Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT (Elements) Dose Review (Elements) Multiple Brain Mets SRS (Elements) Cranial SRS; (Elements) Spine SRS (Elements) Cranial SRS w/ Cones ExacTrac Dynamic Guide 3 Brainlab Elements Guide XT KingMark VoyantMark KingMark Calibration Device VoyantMark Calibration Device Calibration Device VarioGuide Drill Kit LoopX CimMed Brainlab Elements 7 Brainlab Elements BOLD MRI Mapping 1 Brainlab Elements Fibertracking 3 Brainlab Elements Image Fusion 5 Brainlab Elements Contouring 5 Brainlab Elements Image Fusion Angio 1 Automatic Registration ARTPlan Disposable pre-calibrated suction table, surgical with orthopedic accessories Cirq Robotic Alignment Module CIRQ Robotic Alignment Cranial And Spine System Cirq Robotic Alignment Module Cranial Cirq Robotic Alignment System Cirq Cirq Robotic Alignment Cranial And Spine Cirq Robotic Tracking Array Cranial 7.5 DRILL BIT CRANIAL 3.4/3.8 Cirq Robotic Instrument Holder Cranial Cirq Robotic Disposable Kinematic Unit DRILL DEPTH STOP CRANIAL 3.8 iBeam Couchtop iBeam Evo Couchtop Alignment System Spine Cirq Arm System 2 RADIOLUCENT DRAPELINK INTERFACE FOR CALIBRATION PHANTOM INTRAOPERATIVE CT VARIOGUIDE HARDWARE (VERSION G) RADIOLUCENT DRAPELINK ADAPTER FOR DORO SKULL CLAMP Kick 2 Navigation Station Cranial Image Guided Surgery System CALIBRATION PHANTOM ICT DISPOSABLE HEADBAND FOR PATIENT REFERENCE ARRAY (10 PCS) INSTRUMENT TRACKING ARRAY STARLINK SIZE XL RADIOLUCENT DRAPELINK INTERCONNECTOR Gauge for Softouch Registration Pointer INSTRUMENT TRACKING ARRAY STARLINK SIZE ML INSTRUMENT TRACKING ARRAY STARLINK SIZE M DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE M) (3 PCS) ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K) ULTRASOUND NAVIGATION ADAPTER GENERIC HANDLE FOR MULTIPLE TIP POINTER INSTRUMENT ADAPTER CLAMP STARLINK SIZE M RADIOLUCENT DRAPELINK BASE SHORT RADIOLUCENT DRAPELINK BASE LONG Alignment Arm DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE L) (3 PCS) Skull Reference Base INSTRUMENT ADAPTER CLAMP STARLINK SIZE S ADHESIVE REFLECTIVE FLAT MARKERS (10PCS) ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP) INSTRUMENT ADAPTER CLAMP STARLINK FOR RECTANGULAR INSTRUMENTS ULTRASOUND NAVIGATION ADAPTER (BK X18L5S) ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S) INSTRUMENT ADAPTER STARLINK ANGLED 45° RADIOLUCENT DRAPELINK PATIENT REFERENCE ARRAY DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE S) (3 PCS) Skull Reference Array V-INSET-IMRIS KIT INSTRUMENT TRACKING ARRAY STARLINK SIZE L Instrument Calibration Matrix REGISTRATION MATRIX FOR IMRI HEAD HOLDER (NORAS) VARIOGUIDE ARRAY Pat. Ref. Attachment Arm for Skull Clamp ULTRASOUND NAVIGATION TRACKING ARRAY PATIENT REFERENCE ARRAY FOR DISPOSABLE HEADBAND OR-Side-Rail Adapter for Supporting Arm CT Pat. Ref. Array for Skull Clamp RADIOLUCENT DRAPELINK ADAPTER FOR MAYFIELD SKULL CLAMP Pat. Ref. T-Adapter for Skull Clamp V-INSET GE HEADHOLDER KIT INSTRUMENT ADAPTER CLAMP STARLINK SIZE L Pat. Ref. Attachment for Skull Clamp INSTRUMENT ADAPTER CLAMP STARLINK FOR CYLINDRICAL INSTRUMENTS INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL ULTRASOUND NAVIGATION ADAPTER (BK N13C5) NDI Passive Spheres Drill Guide Handle 4-Marker Disp Fixation Pin 4 x 125 mm (10 pcs) C-Arm Adapter GE OEC 3D Right C-Arm Adapter Siemens Cios Spin Right Radiolucent Drapelink Base Short Drill Guide Tube (2.4 mm) Cirq Robotics Tracking Array 10 Instrument Adapter Clamp Starlink Size S Sterilization Tray Accessories Spine Drill Guide Tube 2.6 mm X 200 mm Disposable Trocar Insert Pedicle Access Needle Hex Screwdriver T-Handle 2.5 mm Bone Fixator "1-Pin", X-Press Size-S Instrument Tracking Array Starlink Size ML Sterilization Tray Accessories Spine MIS Registration Matrix Minimally Invasive (Cranial and Spine) C-Arm Adapter GE OEC 3D Left Instrument Adapter Clamp Starlink for Cylindrical Instruments Pedicle Access Needle Guide Tube 1.8 mm Bone Fixator 2-Pin X-Press Drill Bit 2.4 mm AO Shank Radiolucent Drapelink Adapt Mayfield Clamp Drill Bit 3.2 mm AO Shank Trocar Insert 5mm Cirq Instrument Holder Spinal Drilling Drill Guide Depth Control (200mm) Tissue Protection Sleeve Grip Sterilization Tray Registration 3D C-Arm Drill Guide Tube (2 mm) Sterilization Tray Cirq® Robotic Alignment Spine Drill Guide Tube (4.5 mm) Instrument Adapter Starlink Angled 45° Drill Guide Depth Control (0 - 60 mm) Hex Screwdriver 4 mm Alignment Trocar Spine 2.6 Spine & Trauma Navigation Instruments Drill Guide Tube 3 X 150 MM Trocar Sharp Tip 3.2mm (200mm) Instrument Tracking Array Starlink Size M Drill Bit 4.5 mm AO Shank DRAPELINK INTERFACE FOR ICT CALIBRATION PHANTOM Alignment Trocar Spine 6/10 INSTRUMENT TRACKING ARRAY S&T 4-MARKER Bone Fixator "1-Pin", X-Press Size-M Adhesive Reflective Flat Markers Drill Bit 2.6 mm AO Shank Depth Control Radiolucent Drapelink Adapt Doro Skull Clamp HANDLE UNIVERSAL FOR OPEN SURGERY Pat. Ref. T-Adapter for Skull Clamp Instrument Adapter Clamp Starlink Size XL Pat. Ref. Attachment Arm for Skull Clamp Pat. Ref. Array for Skull Clamp Cirq Robotic Disposable Kinematic Unit C-Arm Reference Unit Right Hex Screwdriver Ball-End 2.5 mm Instrument Adapter Clamp Starlink Softgrip Size XL Drill Guide Tube 3.2mm X 200mm Patient Reference Array Y-Geometry X-Press Alignment Guide Tube Spine 3.2/10 Trocar Reduction Sleeve 2mm INSTRUMENT TRACKING ARRAY S&T (SIZE ML) Trocar Reduction Sleeve 2.8mm Drill Guide Trocar Insert (2.6 mm) Trocar Reduction Sleeve 3.2mm Drill Guide Depth Control (60 - 100 mm) CALIBRATION PHANTOM ICT Adapter for Surgical Motor System Chisel Long for Open Surgery Drill Bit 2.4 mm AO Shank Depth Control Drill Guide Trocar Insert (3.2 mm) Drill Bit 3.2 mm Depth Control (200 mm) Patient Reference Array T-Geometry X-Press Adapter Short for Patient Reference Clamp Adapter Long for Patient Reference Clamp Cirq Robotic Instrument Holder Spine Awl (4 mm) for Open Surgery Drill Guide Depth Control Drill Guide Tube 2.6mm X 150mm Trocar Sharp Tip 2.4 mm C-Arm Adapter Ziehm RFD 3D Right Disposable Clip-on Remote Control Cirq Robotic Depth Tracking Array beige Spine Reference Clamp (Carbon) PATIENT REFERENCE ROD-CLAMP SPINE & TRAUMA Drill Guide Trocar Insert (4.5 mm) Drill Guide Trocar Insert (2 mm) Cirq Instrument Holder Module Drill Guide Handle Compact Hex Screwdriver 2.5 mm Alignment Trocar Spine 3.2 C-Arm Adapter Ziehm RFD 3D Left Sterilization Tray Registration Universal Air Radiolucent Drapelink Patient Reference Array Drill Guide Tissue Protection Sleeve 10mm Handheld Registration Device Fluoro 2D Sterilization Tray Drill Guide Drill Guide Tube 4.5mm X 200mm REFLECTIVE DISKS FLUORO KIT REV2-21 PCS Alignment Guide Tube Spine 2.6/10 Drill Guide Depth Control Insertable Drill Bit 3.2 mm AO Shank Depth Control Instrument Adapter Clamp Starlink Size L C-Arm Adapter Siemens Cios Spin Left Drill Guide Array Probe Straight (3.5 mm) for Open Surgery Sterilization Tray Instruments Trauma Trocar Sharp Tip 2.6mm (200mm) Drill Guide Compact Handle 4 Markers Sterilization Tray Accessories Spine & Trauma Drill Bit 2 mm Depth Control 0-60 mm Drill Guide Handle Chisel Short for Open Surgery Drill Bit 4.5 mm Depth Control 0-60 mm Instrument Adapter Clamp Starlink for Rectangular Instruments ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY Trocar Sharp Tip 2.6 mm Registration Matrix CT Spine (Open Surgery) Patient Reference Steel-Clamp Spine & Trauma Size S Instr. Adapter Array (Starlink), Size XL Instrument Adapter Clamp Starlink Softgrip Size L Alignment Depth Control Spine Registration Matrix Small Incision (Spine) Sterilization Tray Registration 2D C-Arm Instr, Adapter Array (Starlink), Size L Drill Guide Tube 2.4 X 150mm Drill Guide Tube (2.6 mm) Instrument Calibration Matrix Alignment Guide Tube Spine 2.4/10 Bone Fixator "1-Pin", X-Press Size-L Drill Bit 3.2 mm Depth Control 60-100 mm Radiolucent Drapelink Base Long C-Arm Reference Unit Left Instrument Adapter Starlink Extension 50 mm Alignment Trocar Spine 2.4 Drill Guide Tube (3.2 mm) Probe Curved (4.5 mm) for Open Surgery INSTRUMENT TRACKING ARRAY S&T 3-MARKER Drill Bit 2.6 mm Depth Control (200 mm) Drill Guide Trocar Insert (2.4 mm) Drill Guide Trocar Tube 5mm X 180mm Cirq Robotic Depth Tracking Array Black Patient Reference Steel-Clamp Spine & Trauma Size L PATIENT REFERENCE ARRAY SPINE & TRAUMA Double Open-End Wrench 10 x 14 mm Pointer Sharp Tip Extended Sterilization Tray Instruments Spine Drill Bit 2.6 mm AO Shank Awl (3 mm) for Open Surgery Sterilization Tray Drill Guides 200 mm Spine Instrument Adapter Clamp Starlink Size M Radiolucent Drapelink Interconnector Drill Bit 4.5 mm Depth Control 60-100 mm Sterilization Tray Cirq® Instrument Holder Spine Instrument Tracking Array S&T (Size L) Trocar Sharp Tip 3.2 mm HANDLE GEARSHIFT FOR OPEN SURGERY Pat. Ref. Attachment for Skull Clamp Drill Guide Tube 3.2mm X150mm Probe Straight (4.5 mm)for Open Surgery RT Elements 4 iPlan Flow Integrated Conical Collimator and Interlock System (ICVI) Alignment Guide Tube Cranial 4/7.5 Alignment Guide Tube Cranial 2.5/7.5 VARIOGUIDE ARRAY 4-MARKER Alignment System Cranial Cirq Alignment Software Cranial Biopsy Alignment Software Cranial DRAPELINK REF ADAPTER AUTO-REG IMRI DRILL BIT CRANIAL 2.4/4 VARIOGUIDE DISC SET CRANIAL DRILL KIT Alignment Reduction Tube Cranial 2.5/4 DRILL BIT CRANIAL 2.1/4 VARIOGUIDE JOINT DISC DRILL DEPTH STOP CRANIAL 2.5 VARIOGUIDE JOINT ARRAY HOLDER Cirq Alignment Software Cranial sEEG Varioguide Alignment Software Cranial VARIOGUIDE DISC SET 1.8 MM TO 4 MM AUTO-REG MATRIX IMRI DRILL BIT CRANIAL 2.1/2.5 Cirq Robotic Instrument Holder Cranial DRILL BIT CRANIAL 2.4/2.5 Cirq Robotic Tracking Array Cranial 7.5 DRILL DEPTH STOP CRANIAL 4 VARIOGUIDE DISC SET 4 MM TO 8 MM DRILL BIT CRANIAL 3.4/3.8 Cirq Robotic Disposable Kinematic Unit VARIOGUIDE JOINT ARM KIT Alignment Guide Tube Cranial 3.8/7.5 Brainlab Flexible Catheter Cranial 4Pi Cranial 4Pi Immobilization TraumaCad Neo ARTPlan HEX SCREWDRIVER T-HANDLE 2.5 MM HEX SCREWDRIVER BALL-END 2.5 MM HEX SCREWDRIVER 4 MM HEX SCREWDRIVER 2.5 MM Frameless Radiosurgery Components Frameless SRS MASK SET EXTENDED (5 PCS.) Frameless SRS CARBON BASE Frameless SRS MASK SET CRANIAL (5 PCS.) Navigation Software Vascular PAD Vascular Navigation PAD 2 Leksell Vantage Stereotactic System ExacTrac Dynamic Automatic Registration Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X Skull Reference Base EM EM Registration Pointer Cranial EM System EM Pointer EM Instrument Tracker EM Patient Reference EM Short Pointer EM Disposable Stylet Brainlab Elements - Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial Disposable Loop-X Source Drape Patient Scan Drape Light Handle Cover 27 Display Drape iCT Scan Drape Disposable Drape for Cirq with Instrument Holder Module Disposable Drape for Cirq® Robotics Kick Monitor Drape Disposable Drap for Ultrasound Registration Phantom Disposable Monitor Drape for Kick Disposable Touch Screen Drape Loop-X Disposable Sterile Drape Set Disposable Loop-X Detector Drape Disposable Loop-X Drape Set pro-cart 35E DISPOSABLE REFLECTIVE MARKER SPHERE Kick Navigation Station Kick Upgrade Navigation Station Navigation SW ENT EM Curve Ceiling-Mounted Kick EM Navigation Station Curve Dual Display Curve 1.1 Dual Navigation Station Curve Single Display Kick 2 Navigation Station Navigation SW CRANIAL EM Kick 2 Navigation Station DPS Registration Software Cranial Microscope Navigation Software Curve 1.2 Dual Navigation Station EM Disposable Stylet Ultrasound Navigation Software (BK) Ultrasound Navigation Buzz Navigation Ceiling Mounted DISPOSABLE STYLET Navigation SW Cranial Automatic Registration iMRI Navigation SW ENT Ultrasound Registration Phantom Disposable Stylet

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-09-12
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2018-06-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-08-31
GXL Screwdriver, Skullplate Neurology Class 1 882.4900 2023-05-02
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2012-05-15
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2012-05-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-11-15
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2020-08-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2019-05-02
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2019-05-02
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2019-05-02
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2024-01-10
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-01-10
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2024-01-10
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2023-04-28
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-04-28
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-02-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-02-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-02-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-05-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-03-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-12-28
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-12-11
HXC Wrench Orthopedic Class 1 888.4540 2023-10-17
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2013-05-29
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2024-07-26
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2012-09-25
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-07-24
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2021-04-21
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2015-09-14
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-02-09
HBM Headrest, Neurosurgical Neurology Class 1 882.4440 2025-09-22
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-08-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2021-12-21
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-12-21
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2018-03-21
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2007-05-17
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2023-07-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-07-17
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-07-17
OUG Medical Device Data System General Hospital Class 1 880.6310 2012-11-07
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2007-11-26
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-06-02
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2025-06-24
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-06-24
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2020-11-13
QQC Brain Stimulation Programming Planning Software. Neurology Class 2 882.5855 2022-04-25
JAC System, X-Ray, Film Marking, Radiographic Radiology Class 1 892.1640 2012-11-16
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2016-03-14
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-07-14
FOX Stand, Infusion General Hospital Class 1 880.6990 2025-02-03
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-06-24
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-06-24
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-06-24
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-05-10
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-02-03
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2025-02-03
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2025-02-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-01-30
JEA Table, Surgical With Orthopedic Accessories, Ac-Powered General, Plastic Surgery Class 1 878.4960 2019-06-14
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-11-15
IXQ Table, Radiographic, Stationary Top Radiology Class 2 892.1980 2015-09-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-11-02
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2020-10-26
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-02-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-09-15
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2023-03-30
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2007-11-26
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2019-02-13
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-09-11
HCA Catheter, Ventricular Neurology Class 2 882.4100 2014-03-07
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-06-24
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-03-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-02-03
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2025-02-03
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2025-02-03
HXX Screwdriver Orthopedic Class 1 888.4540 2016-07-14
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2007-11-26
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-09-01
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-09-01
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-08-23
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2022-05-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-03-22
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2021-01-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-09-12
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-04-21
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2018-12-05
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2023-12-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2010-07-27
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2010-07-27
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2010-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

Paul Neil Business: BRAINLAB, INC. Email: paul.neil@brainlab.com Phone: (708) 4091343

Related Public Records

Same Entity

Brainlab SE
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K092467 Brainlab AG VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED 2010-05-06
K010427 Walter Lorenz Surgical, Inc. LORENZ FIDUCAIL SCREW 2001-03-15
K812744 Progress Mankind Technology LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER 1981-12-03
K031454 Biomet, Inc. ACUMEN SURGICAL NAVIGATION SYSTEM 2004-07-08
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

Similar Registrations

Registration Number Establishment Name Location
3002743211 NORTHERN DIGITAL, INC. WATERLOO Ontario, CA
3009108888 RENISHAW MAYFIELD Chassieu Rhone, FR
3018708317 MAGNUS MEDICAL INC. Burlingame, CA, US
2434444 NEURODYNAMICS, INC. Manhattan, NY, US
3017004815 RENISHAW NEURO SOLUTIONS LTD Wotton-under-Edge Gloucestershire, GB
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043933. Last updated year: 2026. Please use registration number 8043933 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.