Scopis Extended Instrument Set EM
Scopis GmbH
SCOPIS GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011043662 | 3011043662 | SCOPIS GMBH | 1 | N | 2020-04-25 | Heinrich-Heine-Platz 10 Berlin Berlin DE 10179 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 213994 | 1021703777 | K171661 | Scopis Extended Instrument Set EM | PGW | 2017-09-27 |
| 213994 | 1701674757 | K161491 | Scopis Hybrid Navigation System EM | PGW | 2017-02-09 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PGW | 2 | 2017-09-27 |
PMN#
Scopis Hybrid Navigation System EM
Scopis GmbH
GUDID#
Instrument clamp 2-6 mm - The Instrument clamp 2-6 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable.
2018-01-04
Instrument clamp forceps - The Instrument clamp forceps is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable.
2018-01-04
Instrument clamp 6-10 mm - The Instrument clamp 6-10 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable.
2018-01-04
Instrument clamp 10-16 mm - The Instrument clamp 10-16 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable.
2018-01-04
Precision Pointer EM - The Precision Pointer EM is an electromagnetically tracked instrument that is used to register the patient anatomy and to navigate within the anatomical space. The location of the instrument is referenced relative to a patient tracker that is attached to the patient. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable.The Precision Pointer EM is provided non-sterile and is intended to be sterilized by the user. The Precision Pointer EM is reusable.
2018-01-04
Registration pointer EM-D - The Registration Pointer EM-D is an electromagnetically tracked instrument with a rounded, blunt tip that is used to register the patient anatomy. The location of the instrument is referenced relative to a patient tracker affixed to the patient’s anatomy. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable.The Precision Pointer EM-D is provided non-sterile and is intended intended for high-level disinfection only. It is intended to be used prior to surgical draping while the patient environment is not covered under sterile drape. The Registration Pointer EM-D is reusable.
2018-01-04
Suction tube Frazier EM - The Suction tube Frazier EM provides an electromagnetically tracked instrument that is used to navigate within the patient anatomy during surgery. The location of the instrument is referenced relative to a patient tracker that is affixed to the patient’s anatomy. The navigated suction tube connects to the Hybrid Navigation Unit EM via integrated cables.Suction tubes are provided non-sterile and is intended to be sterilized by the user.Suction tubes are reusable.
2018-01-04
Suction tube Eicken EM - The Suction tube Eicken EM provides an electromagnetically tracked instrument that is used to navigate within the patient anatomy during surgery. The location of the instrument is referenced relative to a patient tracker that is affixed to the patient’s anatomy. The navigated suction tube connects to the Hybrid Navigation Unit EM via integrated cables.Suction tubes are provided non-sterile and are intended to be sterilized by the user.Suction tubes are reusable.
2018-01-04
Endoscope tracker EM - 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.
2018-01-04
Calibration body EM - 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.
2018-01-04
Universal Tracker EM - 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.
2018-01-04
Instrument port - 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.
2018-01-04
Instrument clip 4 mm - 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.
2018-01-04
Hybrid Navigation Unit EM - 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.
2018-01-04
Patient tracker tabs (PU 100) - Patient tracker tabs are circular, medical grade, double-sided adhesive tape. They serve to attach the navigation references products Patient tracker EM mini or Patient tracker EM-D mini to the patient during surgery.
2018-01-04
NOVA AR - 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.
2018-04-20
Patient tracker EM mini - The Patient Tracker EM mini provides a reference point on the patient. This reference defines the patient location and is used to correlate the patient anatomy to the image set. The Patient Tracker connects to the Navigation Unit via an integrated cable.The Patient Tracker EM mini is provided non-sterile and is intended to be sterilized by the user.The Patient Tracker EM mini is reusable.
2018-01-04
Patient tracker EM-D mini - The Patient Tracker EM-D mini provides a reference point on the patient. This reference defines the patient location and is used to correlate the patient anatomy to the image set. The Patient Tracker connects to the Navigation Unit via an integrated cable.The Patient Tracker EM-D mini is provided non-sterile and is intended for high-level disinfection only.The Patient Tracker EM-D mini is reusable.
2018-01-04
Field generator planar - 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.
2018-01-04
Field generator mounting arm - 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.
2018-01-04
NOVA AR - 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.
2018-01-04
NOVA AR - 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.
2018-02-20
NOVA Basic - The Navigation Software NOVA Basic provides import of image sets, building the image-based model of patient anatomy, planning of surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
2018-01-04