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    FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·September 2, 2015

    ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·March 21, 2018

    ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·May 7, 2014

    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 13, 2014

    Bare Fiber 320/385 IR HFPI 1 Stück

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·advanced fiber tools GmbH·1 device

    Bare Fiber 320/385 IR HFPI 5 Stück

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·advanced fiber tools GmbH·1 device

    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·December 6, 2017

    Dr. Franz Köhler Chemie GmbH

    Manufacturer
    🇩🇪 Germany

    Fette Pharma GmbH

    Manufacturer
    🇩🇪 Germany

    Murnauer Markenvertrieb GmbH

    Manufacturer
    🇩🇪 Germany

    DermaTools Biotech GmbH

    Manufacturer
    🇩🇪 Germany

    ImmuChrom GmbH

    Manufacturer
    🇩🇪 Germany

    LSK-Wintrich GmbH

    Manufacturer
    🇩🇪 Germany

    Dr. Wittmann GmbH & Co. KG

    Manufacturer
    🇩🇪 Germany·1 Basic UDI-DI·1 Device

    VEPRO AG

    Manufacturer
    🇩🇪 Germany·1 Basic UDI-DI·1 Device·DQS Medizinprodukte GmbH

    Acousticon Hörsysteme GmbH

    Manufacturer
    🇩🇪 Germany·7 Basic UDI-DIs·11 Devices

    Nucleoss Europe GmbH

    Manufacturer
    🇩🇪 Germany·125 Basic UDI-DIs·143 Devices·Szutest Uygunluk Değerlendirme A.Ş. and Szutest Uygunluk Değerlendirme A.Ş.

    Wareg Verpackungs GmbH

    Manufacturer
    🇩🇪 Germany

    SWL Medizin GmbH

    Manufacturer
    🇩🇪 Germany·1 Basic UDI-DI·1 Device·Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi