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#
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
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
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 o
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 o
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
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 su
2018-04-20
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 anatomic
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
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
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
2018-01-04
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 patien
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 pati
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 reference
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
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 instr
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 o
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
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 n
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.
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.
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 su
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 su
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,
2018-01-04