BIOSERENITY MEDICAL DEVICES GROUP 1001-10004-US Neuronaute 1.2 - Head module

The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/acces professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MKII is not intended for use in diagnosis, nor in critical and/or life supporting applications.The NeXus 10 MKII is intended for use on humans.The NeXus 10 MKII is intended to be used with approved NeXus 10 MKII accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus-10 MKII and may require interpretation by user or application software.

A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to reinforce their skills in acceptance and commitment therapy.

A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to build their skills in acceptance and commitment therapy.

Ultrasound Navigation 1.2 is software that runs on a Brainlab IGS platform or Brainlab navigation system which consists of a computer, a display and an infrared (IR) tracking camera. It can be used in conjunction with other Brainlab Image Guided Surgery (IGS) software. Designed to assist during surgeries, it provides intraoperative ultrasound functionality by:- Linking the 2D ultrasound view to preoperative patient image data by overlaying the 2D ultrasound image with the patient image data (e.g., CT/MR and derived data such as segmented objects, fibers, etc.).- Acquiring 3D ultrasound data sets consisting of 2D ultrasound image slices and enabling navigation and viewing with other Brainlab IGS software, as well as further processing of this data.

ALLEN HEAD RESTRAINT

The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/acces professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MKII is not intended for use in diagnosis, nor in critical and/or life supporting applications.The NeXus 10 MKII is intended for use on humans.The NeXus 10 MKII is intended to be used with approved NeXus 10 MKII accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus-10 MKII and may require interpretation by user or application software.

A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to reinforce their skills in acceptance and commitment therapy.

A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to build their skills in acceptance and commitment therapy.

Ultrasound Navigation 1.2 is software that runs on a Brainlab IGS platform or Brainlab navigation system which consists of a computer, a display and an infrared (IR) tracking camera. It can be used in conjunction with other Brainlab Image Guided Surgery (IGS) software. Designed to assist during surgeries, it provides intraoperative ultrasound functionality by:- Linking the 2D ultrasound view to preoperative patient image data by overlaying the 2D ultrasound image with the patient image data (e.g., CT/MR and derived data such as segmented objects, fibers, etc.).- Acquiring 3D ultrasound data sets consisting of 2D ultrasound image slices and enabling navigation and viewing with other Brainlab IGS software, as well as further processing of this data.