Address: Kapellenstr. 12, Feldkirchen 85622, Germany
Phone: +49-(89)-99 15 68 0 | Fax: +49-(89)-99 15 68 33 | Map/Directions >>

Profile: BrainLAB AG supplies software for minimally invasive therapies, as well as for cancer treatments. We develop software and medical systems for the radiation of tumors, as well as the navigation of surgical instruments within the human body. VectorVision® trauma is a trauma navigation software for fracture treatments, which is designed especially for trauma interventions.Our iPlan® BOLD MRI Mapping Software provides a significant leap in neurosurgical planning by integrating BOLD MRI (Blood Oxygen Level Dependent functional MRI) data directly into the OR and image-guided surgery. Our Softouch® pointer provides quick surface matching registration for greater flexibility and ease in patient setup. Our Kolibri ™spine makes image-guided spine navigation technology easy to use, with a short learning curve and a seamless integration into the surgical procedure. It is available on our lightweight, & mobile Kolibri platform.

FDA Registration Number: 8043933
US Agent: Paul Neil / Brainlab, Inc.
Phone: +1-(708)-409-1343  Fax: +1-(708)-409-1619  E-Mail:

27 Products/Services (Click for related suppliers)  
• 3D Imaging Devices
• Contract Manufacturers
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• IGRT (Image-guided Radiation Therapy) Device
• Image-guided Radiation Therapy Accessories
• Image-guided Surgery Kits
• IMRT (Intensity Modulated Radiation Therapy) Devices
• Integrated OR Systems
• Intensity Modulated Radiation Therapy Accessories
• Medical Charged-Particle Radiotherapy Unit (FDA Code: LHN / 892.5050)
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
• Medical Linear Accelerator (FDA Code: IYE / 892.5050)
• Neurological Stereotaxic Instrument (FDA Code: HAW / 882.4560)
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
• Orthopedic Stereotaxic Instrument (FDA Code: OLO / 882.4560)
• Positioning System Accessories
• Powered Radiation Therapy Couch (FDA Code: JAI / 892.5770)
A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.
• Radiation Oncology Device Accessories
• Radiation Oncology Kits
• Radiation Therapy Accessories
• Radiation Therapy Kits
• Radiation Therapy Positioning Equipment
• Radiation Therapy Treatment Planning System (FDA Code: MUJ / 892.5050)
• Radiographic Anthropomorphic Phantom (FDA Code: IXG / 892.1950)
A radiographic anthropomorphic phantom is a device intended for medical purposes to simulate a human body for positioning radiographic equipment.
• Radiological Digital Image Communication System (FDA Code: LMD / 892.2020)
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol.
• Radiological Image Processing System (FDA Code: LLZ / 892.2050)
A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.
• Radionuclide Brachytherapy Source (FDA Code: KXK / 892.5730)
A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.
• Stereotactic Frames/Planning Systems
• Treatment Systems

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