Address:Heinrich-Heine-Platz 10,Berlin,DE
Device Description : The Endoscope tracker EM provides a way to track the location of compatible conv The Endoscope tracker EM provides a way to track the location of compatible conventional rigid endoscopes. The location of the instrument is referenced relative to a patient tracker. The Endoscope tracker EM connects to the Hybrid Navigation Unit EM via an integrated cable.The Endoscope tracker EM is provided non-sterile and is intended to be sterilized by the user.The Endoscope tracker EM is reusable.
Device Class : 2
Duns Number: 341702266
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Calibration body EM is used to calibrate a surgical endoscope which is track The Calibration body EM is used to calibrate a surgical endoscope which is tracked with Endoscope tracker EM. The location of the Calibration Body EM is referenced relative to the Endoscope tracker EM and allows Navigation Software NOVA AR to compute the optical parameters of the attached surgical endoscope. The Calibration body EM connects to the Hybrid Navigation Unit EM via an integrated cable.The Calibration body EM is provided non-sterile and is intended to be sterilized by the user.The Calibration body EM is reusable.
Device Class : 2
Duns Number: 341702266
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Universal tracker EM provides a way to track the location of compatible conv The Universal tracker EM provides a way to track the location of compatible conventional surgical instruments. It is mounted on the conventional instrument with a suitable instrument clamp and calibrated to navigate the tip of instrument. The Universal tracker EM connects to the Hybrid Navigation Unit EM via an integrated cable.The Universal tracker EM is provided non-sterile and is intended to be sterilized by the user.The Universal tracker EM is reusable.
Device Class : 2
Duns Number: 341702266
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Instrument port is a sterile handling port for the other EM navigated instru The Instrument port is a sterile handling port for the other EM navigated instruments. The Instrument port connects to the Hybrid Navigation Unit EM on one side and to an EM navigated instrument on the other.The Instrument port is provided non-sterile and is intended to be sterilized by the user.The Instrument port is reusable.
Device Class : 2
Duns Number: 341702266
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Instrument clip EM 4 mm provides a way to track the location of compatible c The Instrument clip EM 4 mm provides a way to track the location of compatible conventional surgical instruments. After performing a calibration step the tip of the conventional instrument can be navigated. The clip connects to the Hybrid Navigation Unit EM via an integrated cable.The clip is provided non-sterile and is intended to be sterilized by the user.The Instrument clip EM 4 mm is reusable.
Device Class : 2
Duns Number: 341702266
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Hybrid Navigation Unit EM is a high performance computer workstation with bu The Hybrid Navigation Unit EM is a high performance computer workstation with built-in electromagnetic Localization System. The workstation runs the navigation software NOVA which imports radiologic image via DICOM.
Device Class : 2
Duns Number: 341702266
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Scopis Hybrid Navigation System EM utilizes the Field Generator planar to cr The Scopis Hybrid Navigation System EM utilizes the Field Generator planar to create the electromagnetic field for navigation of surgical instruments.The EM Field Generator planar is connected to a mounting arm for placement close to the surgical area.
Device Class : 2
Duns Number: 341702266
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Field generator mounting arm serves as a mounting for the Field generator. T The Field generator mounting arm serves as a mounting for the Field generator. The screw at its central hinge locks the position of all three joints. The base of the arm is clamped to the standard rail mount of surgical operation tables.
Device Class : 2
Duns Number: 341702266
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Navigation Software NOVA AR provides import of image sets, building the imag The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Device Class : 2
Duns Number: 341702266
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Navigation Software NOCA AR provides import of image sets, building the imag The Navigation Software NOCA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Device Class : 2
Duns Number: 341702266
Premarket Exempt : No
Prescription Use : Yes