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Version 6.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement.
Version 7.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN), globus pallidus externa and interna (GPe and GPi, respectively) and the ventral intermediate nucleus (Vim) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement.
Surgical Information Sciences Inc.
6.X.X, 7.X.X
In Commercial Distribution
- 00860001580907 ()
- Stereotactic system application software
Personalized PseudoPatient™ PV FL
RTSAFE, INC.
PFL-02PV
In Commercial Distribution
- 00860001523218 ()
PFL-02PV
- Custom-made organ/bone anatomy model
Personalized PseudoPatient™ PV IC
RTSAFE, INC.
PIC-02PV
In Commercial Distribution
- 00860001523201 ()
PIC-02PV
- Custom-made organ/bone anatomy model
Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo headphones with integrated treatment electrodes. Cervella provides stimulation current intensity ranging from 50uA - 500uA in 50uA increments and user-selectable frequency presets of 0.5Hz, 1.5Hz, and 100Hz.
INNOVATIVE NEUROLOGICAL DEVICES LLC
Cervella CES
In Commercial Distribution
- 00860001493306 ()
Cervella
- Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
RestoreX Kit - penile traction therapy device for the treatment of Peyronie's disease. Contains RestoreX device, extension rods, self-adherent wrap, Instructions for Use
PATHRIGHT MEDICAL INC.
117
In Commercial Distribution
- 00860001453805 ()
117
- Penile traction splint
No Description
HILL LABORATORIES CO.
HF54, Horizon
In Commercial Distribution
- 00860001452532 ()
- Physical therapy ultrasound system
FlowerRope
TENSYN MEDICAL, INC.
DLF 001
Not in Commercial Distribution
- 00860001412215 ()
- Tendon/ligament bone anchor, non-bioabsorbable
FlowerRope
TENSYN MEDICAL, INC.
FOR 001
Not in Commercial Distribution
- 00860001412208 ()
- Tendon/ligament bone anchor, non-bioabsorbable
TrueSpin
MEDTOX DIAGNOSTICS, INC.
S001
In Commercial Distribution
- 00860001286564 ()
- General-purpose centrifuge IVD
CABLE FMET-IM-RSC
MEDTRONIC, INC.
FMET-IM-RSC
In Commercial Distribution
- 00860001276138 ()
- Laser speckle blood flowmeter