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The DORO LUCENT® Skull clamp is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The DORO LUCENT® Skull clamp Pediatric Set is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The target patient population includes children over 5 years of age.

The DORO LUCENT® Skull Clamp ensures an adequate positioning of a patient's head and provides rigid fixation for neurosurgery. The device is suitable for intra-operative X-ray and CT based imaging procedures. The DORO LUCENT® Skull Clamp consists of a fixed arm, an adjustable arm and modular pin holders. Thus, using the DORO LUCENT® Skull Clamp Pediatric Set, the skull clamp can be configured as three-pin or four-pin pediatric set up.

The DORO QR3 Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.

DORO® QR3 Headrest System consists of 3 components: 1. Skull clamp, 2. Swivel Adapter, 3. Adjustable Base Unit. DORO® QR3 Headrest System (Aluminum) is a cranial stabilization device, designed to provide rigid skeletal fixation. The DORO Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. The Swivel Adaptor connects the Base Unit (by means of the Transitional Member) with the Skull Clamp. The Swivel Adaptor provides 360 degrees rotation. This allows a fully flexible adjustment of the DORO® Headrest System to the patient's position. The Base Unit is designed for patient positioning in prone or supine, lateral and sitting positions.

Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

DORO® Sterile Disposable Skull Pins are a disposable device. These are delivered sterile (gamma-sterilization), ready for use, and are intended to be disposed after one use. DORO® Sterile Disposable Skull Pins are available in 2 different types (Stainless steel & Titanium) and 2 different sizes (Adult & Pediatric). DORO® Sterile Disposable Skull Pins are used together with the DORO ® Headrest Systems, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures. Two DORO® Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one single skull pin is inserted in the opposite side. DORO® Sterile Disposable Skull Pins (Titanium) are used when Intra-Operative X-Ray-, CTor MR Imaging of the patient is used.

The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used. The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used. The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.

The DORO LUCENT® iXI and iMRI Headrest System ensures an adequate positioning of a patient's head for neurosurgery. Additional intra-operative imaging can be performed. The DORO LUCENT® iXI and iMRI Headrest System consists of the following: Skull Clamp, Skull Pins, Parallelogram Adaptor and Headplate. The Parallelogram Adaptor is used to connect the Skull Clamp (including Skull Pins) or the Headplate to the OR-Table/ Transfer Board. Additional accessories like the Adjusting wrench and Transfer Collision Indicator supports the performance of the Headrest System. These special Headrest Systems are developed for selected OR-Table/ MRI scanner combinations. They are separated in following sets: - . 4003.200 DORO LUCENT® Headrest System TRUMPF for SIEMENS Aera/Skyra MRI Systems - 4003.300 DORO LUCENT® iMRI Headrest System MAQUET for SIEMENS/PHILIPS/GE ● - . 4003.500 DORO LUCENT® iXI Headrest System By the use of the Navigation Adaptors the performance of the Headrest System is supplemented. The intra-operative navigation is feasible because of the provided interface to the navigation device.

The Arcus Head Fixation Frame is intended for use as a device to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

The Arcus Head Fixation Frame is a re-usable, non-sterile device designed to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets. It consists of a Ring that secures the patient's skull with skull pins, a Base that secures the Ring, and Posts that hold Fixation Screws. The device is secured to the scanner table. It is designed for use with specific Siemens MRI Scanners. The device is MR Conditional and contains brass inserts and titanium pin tips.

The DORO® QR3 XTom Headholder System is a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging with a CT-Scanner is used.

The DORO® QR3 XTom Headholder System ensures an adequate positioning of a patient's head for neurosurgery. Due to the utilized material the device can be used for intraoperative CT imaging procedures. The DORO® QR3 XTom Headholder System consists of the following: Skull Clamp, Skull Pins, Base Unit, Torque Screw Driver and U-Belt. The Base Unit is used to connect the Skull Clamp (including Skull Pins) to the OR-Table. Additional components like the Torque Screw Driver and U-Belt supports the performance of the Headholder System.

The TZ Medical skull pin is placed in a clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

The TZ Skull Pin is a sterile cervical traction skull pin manufactured from implant grade 316L stainless steel alloy. The TZ Skull Pin is used during neurosurgical procedures to immobilize the head in reference to the torso and to provide cervical immobilization.

The MAYFIELD Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.

The MAYFIELD Skull Clamp is a cranial stabilization device, designed to provide rigid skeletal fixation. The MAYFIELD Skull Clamp supports a 2-pin rocker arm, which allows for 360° rotation under full impingement force. The device has the means for skull pin force

The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

The IMRIS Head Fixation Device System (HFD100) Rocker Arm Accessory is an MR compatible mechanical support system intended to use in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The HFD100 and its accessories are designed to immobilize the head during surgical procedures and support patient in the prone, supine or lateral positions. The HFD100 system is comprised of the table adapter, linkage system, one or two rocker arm skull clamps, and skull pins. The HFD100 system can be used with either the operating room table or the angiography room table. The table adaptor is used to mount HFD100 on the table. The linkage system is used to mount the Skull Clamp (including 3 or 4 skull pins) to the table Adapter. The Skull Clamp requires the use of three (3) or four (4) Skull Pins. IMRIS is using MAYFIELD® Disposable and Reusable Titanium Skull Pins manufactured by Integra LifeSciences Corporation and cleared by FDA K072208. The MAYFIELD® Disposable and Reusable Titanium Skull Pins are used in surgical procedures when rigid fixation is desired and Intra-Operative MR imaging is used. IMRIS 3-pin and 4-pin HFD100 attached to the OR table assembly is part of the IMRISneuro system. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. The HFD100 can be used individually or with the IMRIS Flexible Intra-operative Head Coils and third party accessories, such as retractor systems and navigation mounts. The HFD100 provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. The IMRISneuro 1.5T/3T Systems (Neuro III-SV) are traditional MRI units that have been suspended on an overhead rail system to facilitate intra-operative, interventional and diagnostic use. The main components of the IMRISneuro systems are the MRI system, the magnet mover system, the OR Table assembly, the Intra-operative Coil and the Head Fixation Device. The IMRISneuro intraoperative imaging systems are tools for radiologists and surgeons, used to acquire images for diagnosis and surgical planning and monitoring during surgery. When images are requested by the surgeon, the magnet is brought into the operating room or Angiography room moving on a pair of overhead rails. The patient remains stationary throughout the procedure and the magnet moves into the room and over the patient for imaging. The magnet can be moved into and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. The surgeon has access to updated MR images in the surgical field, but does not have to change the surgery would typically be performed. Obtaining images intra-operatively allows surgeons to verify the absence of surgical complications before releasing the patient from the operating room.