FDA Registration Active 🇩🇪 Germany

BRAINLAB SE

Reg #: 8043933 · FEI: 3002619595 · Expires 2026
Products
37
Proprietary Names
594
Establishment Types
2
Classifications
37

Registration Details

Registration Name
BRAINLAB SE
Registration Number
8043933
FEI Number
3002619595
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Olof-Palme-Strasse 9
City
Munich Bavaria
Country
DE

Regulatory Submissions

510(k) Number
K190250

Owner / Operator

Firm Name
Brainlab SE
Operator Number
9004547
Address
Olof-Palme-Strasse 9
City
Munich
State
Bavaria
Postal Code
81829
Country
DE

US Agent

Business Name
BRAINLAB, INC.
Contact Name
Paul Neil
Address
5 Westbrook Corporate Ctr Ste 1000
City
WESTCHESTER
State
IL
ZIP
60154
Country
US
Phone
708 4091343

Products

Device Name Product Code
Neurological Stereotaxic Instrument HAW
Camera, Surgical And Accessories KQM
Orthopedic Stereotaxic Instrument OLO
Screwdriver, Skullplate GXL
System, Image Processing, Radiological LLZ
System, X-Ray, Tomography, Computed JAK
Accelerator, Linear, Medical IYE
System, Radiation Therapy, Charged-Particle, Medical LHN
Radiological Image Processing Software For Radiation Therapy QKB
System, Planning, Radiation Therapy Treatment MUJ
Ear, Nose, And Throat Stereotaxic Instrument PGW
System, Imaging, Pulsed Echo, Ultrasonic IYO
Transducer, Ultrasonic, Diagnostic ITX
System, Imaging, Pulsed Doppler, Ultrasonic IYN
Wrench HXC
Holder, Head, Neurosurgical (Skull Clamp) HBL
Display, Cathode-Ray Tube, Medical DXJ
Headrest, Neurosurgical HBM
System, Digital Image Communications, Radiological LMD
Automated Radiological Image Processing Software QIH
Medical Device Data System OUG
Brain Stimulation Programming Planning Software. QQC
System, X-Ray, Film Marking, Radiographic JAC
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
Interventional Fluoroscopic X-Ray System OWB
Stand, Infusion FOX
Table, Surgical With Orthopedic Accessories, Ac-Powered JEA
Table, Radiographic, Stationary Top IXQ
Catheter, Ventricular HCA
Screwdriver HXX
Drape, Surgical, Exempt PUI
Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
Phantom, Anthropomorphic, Radiographic IXG
Orthopedic Augmented Reality SBF
Electromyograph, Diagnostic IKN
Stimulator, Electrical, Evoked Response GWF
Tray, Surgical, Instrument FSM

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 ENT EM Skull Reference Base EM EM Registration Pointer EM Instrument Tracker 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 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 Guide Trocar Insert (2.4) Drill Guide Drill Guide Trocar Insert (4.5) 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 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 Cranial Navigation Navigation Software Cranial Navigation Software Craniofacial DRAPELINK REF ADAPTER AUTO-REG IMRI Ultrasound Navigation Buzz Navigation (Ceiling Mounted) Automatic Registration iMRI Cranial EM System EM Stylet 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 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 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 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 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 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 Tracking Array Cranial 7.5 DRILL BIT CRANIAL 3.4/3.8 Cirq Robotic Instrument Holder Cranial DRILL DEPTH STOP CRANIAL 3.8 iBeam Couchtop iBeam Evo Couchtop Cirq Arm System 2 VARIOGUIDE HARDWARE (VERSION G) RADIOLUCENT DRAPELINK ADAPTER FOR DORO SKULL CLAMP Cranial Image Guided Surgery System DISPOSABLE HEADBAND FOR PATIENT REFERENCE ARRAY (10 PCS) RADIOLUCENT DRAPELINK INTERCONNECTOR Gauge for Softouch Registration Pointer DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE M) (3 PCS) ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K) ULTRASOUND NAVIGATION ADAPTER GENERIC HANDLE FOR MULTIPLE TIP POINTER RADIOLUCENT DRAPELINK BASE SHORT RADIOLUCENT DRAPELINK BASE LONG Alignment Arm DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE L) (3 PCS) Skull Reference Base ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP) INSTRUMENT ADAPTER CLAMP STARLINK FOR RECTANGULAR INSTRUMENTS ULTRASOUND NAVIGATION ADAPTER (BK X18L5S) ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S) RADIOLUCENT DRAPELINK PATIENT REFERENCE ARRAY DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE S) (3 PCS) Skull Reference Array V-INSET-IMRIS KIT 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 Pat. Ref. Attachment for Skull Clamp INSTRUMENT ADAPTER CLAMP STARLINK FOR CYLINDRICAL INSTRUMENTS ULTRASOUND NAVIGATION ADAPTER (BK N13C5) NDI Passive Spheres 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 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 Sterilization Tray Registration 3D C-Arm Sterilization Tray Cirq® Robotic Alignment Spine Instrument Adapter Starlink Angled 45° Drill Guide Depth Control (0 - 60 mm) Hex Screwdriver 4 mm 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 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 Instrument Adapter Clamp Starlink Size XL 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 Trocar Reduction Sleeve 2mm Trocar Reduction Sleeve 2.8mm Drill Guide Trocar Insert (2.6 mm) Trocar Reduction Sleeve 3.2mm Drill Guide Depth Control (60 - 100 mm) 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 Awl (4 mm) for Open Surgery 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 Spine Reference Clamp (Carbon) PATIENT REFERENCE ROD-CLAMP SPINE & TRAUMA Drill Guide Trocar Insert (4.5 mm) Drill Guide Trocar Insert (2 mm) Hex Screwdriver 2.5 mm 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 Drill Guide Tube 4.5mm X 200mm Drill Bit 3.2 mm AO Shank Depth Control Instrument Adapter Clamp Starlink Size L C-Arm Adapter Siemens Cios Spin Left Probe Straight (3.5 mm) for Open Surgery Sterilization Tray Instruments Trauma Trocar Sharp Tip 2.6mm (200mm) Sterilization Tray Accessories Spine & Trauma Drill Bit 2 mm Depth Control 0-60 mm 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 Registration Matrix Small Incision (Spine) Sterilization Tray Registration 2D C-Arm Instr, Adapter Array (Starlink), Size L Drill Guide Tube 2.4 X 150mm 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 Probe Curved (4.5 mm) for Open Surgery 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 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 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 DRILL BIT CRANIAL 2.1/2.5 DRILL BIT CRANIAL 2.4/2.5 DRILL DEPTH STOP CRANIAL 4 VARIOGUIDE DISC SET 4 MM TO 8 MM VARIOGUIDE JOINT ARM KIT Alignment Guide Tube Cranial 3.8/7.5 Brainlab Flexible Catheter Cranial 4Pi TraumaCad Neo 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 Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X 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 Navigation SW CRANIAL EM Kick 2 Navigation Station DPS Registration Software Cranial Microscope Navigation Software Curve 1.2 Dual Navigation Station Ultrasound Navigation Software (BK) Buzz Navigation Ceiling Mounted DISPOSABLE STYLET Navigation SW Cranial Navigation SW ENT Ultrasound Registration Phantom Disposable Stylet ExacTrac Dynamic 2.2 RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review Constancy Phantom NORMI Spine Planning 2 Mixed Reality Spine Navigation 1.1 Mixed Reality Spine Navigation 1 Viewer (5.4) Elements Image Fusion Elements Cranial Distortion Correction Elements Contrast Clearance Analysis Image Fusion Elements Spine Curvature Correction Elements Virtual iMRI Cranial Spine Planning Spine & Trauma 3D Navigation Elements Screw Planning Spine Spine & Trauma Navigation System Elements Spine Screw Planning Navigation Software Spine& Trauma 3D DRILL BIT 4.5 MM AO SHANK DRILL BIT 3.2 MM AO SHANK DEPTH CONTROL DRILL BIT 2.6 MM AO SHANK DRILL BIT 3.2 MM AO SHANK DRILL BIT 2.4 MM AO SHANK DEPTH CONTROL DRILL BIT 2.6 MM DEPTH CONTROL (200 MM) DRILL BIT 2.6 MM AO SHANK DEPTH CONTROL DRILL BIT 3.2 MM DEPTH CONTROL (200 MM) DRILL BIT 2.4 MM AO SHANK Nexstim NBS 5 Sterilization Tray Cirq® Robotic Alignment sEEG VarioGuide Disc Set 4mm to 8mm Auto-Reg Matrix iMRI Alignment Guide Tube Cranial 4.9 mm / 8 mm VarioGuide Disc Set 1.8mm to 4mm Alignment Reduction Tube Cranial 8 mm / 10 mm Drill Depth Stop Cranial 4.9 mm Automatic Registration iMRI 1.1 Drill Bit Cranial 3.4/3.8 Automatic Registration 2.5 Alignment Software Cranial with LITT 2.1 Drill Depth Stop Cranial 4 Cranial IGS System Automatic Registration iMRI 1 VarioGuide Joint Arm Kit Sterilization Tray Cirq® Robotic Alignment LITT Alignment Bone Anchor Cranial 2.1/3.8 Drapelink Ref Adapter Auto-Reg iMRI Drill Bit Cranial 2.1/4 Drill Bit Cranial 2.1/2.5 VarioGuide Array 4-Marker Drill Bit Cranial 2.4/ 4 Sterilization Tray VarioGuide® Alignment System Cirq Alignment Software Cranial LITT VarioGuide Alignment Software Cranial Drill Depth Stop Cranial 2.5 VarioGuide Array Holder Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm Drill Depth Stop Cranial 3.8 Sterilization Tray Cirq® Robotic Alignment Biopsy Drill Bit Cranial 4.5 mm /4.9 mm Drill Bit Cranial 2.4/2.5 Cirq Robotic Tracking Array 10 Alignment System Cranial, with Alignment Software Cranial with LITT VarioGuide Joint Disc VarioGuide Disc Set Cranial Drill Kit Automatic Registration 2.6 Automatic Registration 2.7 Disposable Pre-calibrated Brain Biopsy Needle 2 Magic Leap STERILIZATION TRAY ACCESSORIES ENT/CMF, STERI TRAY ACCESSORIES ENT/CMF STERILIZATION TRAY ACCESSORIES CRANIAL (2 OF 2), STERI TRAY ACCESSORIES CRANIAL (2 OF 2) STERILIZATION TRAY VARIOGUIDE® ALIGNMENT SYSTEM, STERI TRAY VARIOGUIDE® ALIGNMENT SYSTEM STERILIZATION TRAY INSTRUMENTS TRAUMA, STERI TRAY INSTRUMENTS TRAUMA STERILIZATION TRAY REGISTRATION 2D C-ARM, STERI TRAY REGISTRATION 2D C-ARM STERILIZATION TRAY CIRQ® INSTRUMENT HOLDER SPINE, STERI TRAY CIRQ® INSTRUMENT HOLDER SPINE STERILIZATION TRAY REGISTRATION UNIVERSAL AIR, STERI TRAY REGISTRATION UNIVERSAL AIR STERILIZATION TRAY ACCESSORIES CRANIAL (1 OF 2), STERI TRAY ACCESSORIES CRANIAL (1 OF 2) STERILIZATION TRAY ACCESSORIES EM (1 OF 2), STERI TRAY ACCESSORIES EM (1 OF 2) STERILIZATION TRAY REGISTRATION 3D C-ARM, STERI TRAY REGISTRATION 3D C-ARM STERILIZATION TRAY INSTRUMENTS SPINE, STERI TRAY INSTRUMENTS SPINE STERILIZATION TRAY DRILL GUIDES 200 MM SPINE, STERI TRAY DRILL GUIDES 200 MM SPINE STERILIZATION TRAY ACCESSORIES EM (2 OF 2), STERI TRAY ACCESSORIES EM (2 OF 2) STERILIZATION TRAY DRAPELINK CRANIAL, STERI TRAY DRAPELINK CRANIAL STERILIZATION TRAY ACCESSORIES SPINE MIS, STERI TRAY ACCESSORIES SPINE MIS STERILIZATION TRAY CIRQ® ROBOTIC ALIGNMENT SPINE, STERI TRAY CIRQ® ROBOTIC ALIGNMENT SPINE STERILIZATION TRAY ACCESSORIES SPINE, STERI TRAY ACCESSORIES SPINE Disposable Biopsy Needle Mint Lesion

Establishment Types

Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device