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The disposable guide KDNG00 is dedicated for endocavity diagnosis ultrasound needle guided procedure. It is intended for clinicians and assistant clinic and hospital, to guide linear instrument with a transrectal approach.

The products concerned are plastic guides designed to be clipped on an endocavity ultrasound probe (KOELIS probes K3DEC00/K3DEC00-2 cleared under K170521), to guide a linear instrument through transrectal access. The disposable guides KDNG00 are packaged individually in pouches and delivered sterile. Pouches are then gathered in dispenser boxes (24 guides/dispenser box).

The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions. 1. Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for guiding needles during ultrasound-guided interventions for diagnosis and treatment. 1. a. CON-LEAD range and LIN-LEAD range The guides from CON-LEAD range and LIN-LEAD range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment. 1. b. PERINE range The guides from the PERINE range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment on adult males. 1. Steady Pro range The Steady Pro range provides physician a tool for performing ultrasound-guided interventions with the use of an endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and cancer treatment.

The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are intended to provide a fixed path for needle insertion during ultrasound-guided interventions. The path is aligned with the ultrasound scan plane for needle imaging during the procedure. The ultrasound system can visualize the prospective path (as an on-screen guideline) in the ultrasound image to help needle positioning. CON-LEAD range and LIN-LEAD range: The guides have an attachment system in which a perforated part is attached in order to place a needle. It is a system with removable parts (nails) to adapt to the different diameters of needles. The guides shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices. It is delivered cleaned but not sterile. PERINE range: The guides have an attachment system in which a perforated part is attached in order to place a needle. For some applications, there is a system with removable parts (nails) to adapt to the different diameters of needles. There is a possibility to have a fix or a movable system depending on the guide chosen. The guides shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices. It is delivered cleaned but not sterile. Steady Pro range: The Steady Pro range is a system which holds a 2D/3D lateral-fire endocavitary or 2D/3D endfire endocavitary ultrasound probe. It is an accessory of KOELIS systems. The main functions are to move the probe freely inside the working space of the probe holder in unlocked state, to maintain the probe in a specific position for an extended time when locked, to provide 6 degrees of freedom (rotation + translation) for arm and probe positioning, easy to use, sterilizable and cleanable, easy to cover and protect.

Ultrasound System TRINITY and its embedded 3D PROSTATE SUITE software are intended to be used by clinicians and their assistants. qualified to perform ultrasound diagnosis and ultrasound-guided procedures, in public or private hospitals. TRINITY is indicated to: · Generate ultrasound images for structural analysis and fluid flow analysis for o urology, o gynecology, o vascular. o abdominal, o small organs. o soft tissues and o musculoskeletal exams TRINITY is not indicated for ophthalmic and cranial ultrasonography. Medical Imaging Processing System 3D-PROSTATE SUITE, embedded on TRINITY or other KOELIS systems that do not integrate a 3D ultrasound module, is indicated to: · Process, visualize and record various 2D and 3D image modalities (such as Ultrasound images, MRI) · Fuse images of various modalities · Display organ and perform measurements · Display cartographies of prostate interventions (instrument positions) · Manage patient data · Import and export of data and images

TRINITY is an electro medical system considered as a system composed of: - A mobile workstation composed by a central unit with ultrasound beamformer, a tactile ● screen, a mouse, a touch pen and a footswitch, all assembled on a mobile cart. Options, as keyboard and trackball mouse, can be delivered. - 0 Ultrasonic probe: 2D/3D end-fire endocavity probe and/or 2D/3D side-fire endocavity probe. 2D probes can be optionally delivered. - 3D PROSTATE SUITE software composed of the base software and PROMAP –Ty that drives the 0 ultrasound module and performs additional measuring functions. The system generates ultrasound waves in the low megahertz range, typically from 1 Mhz to 20 Mhz. Two main ultrasound modes are provided by the system: B-mode imaging for structural analysis and Doppler imaging (including color flow sub-mode and power sub-mode) for body fluid flow analysis. - B-mode imaging measures the time and waveform differences between wave emission and o wave reception to reconstruct an image. - 0 Doppler imaging uses in addition the Doppler Effect to show flow direction and to inform about relative velocity (no measurement) (color flow sub-mode) or to show flow strength (power sub-mode). The system also provides 3D B-mode imaging for high quality ultrasound acquisition of anatomical volumes. The technology employed is volume-swept 3D ultrasound.

TRINITY® Ultrasound and Medical Imaging Processing System is intended to be used by clinicians and their assistants. The device is indicated to generate, visualize and record 2D and 3D ultrasound images. In the particular context of prostate biopsy, the device embedding the 3D PROSTATE SUITE SOFTWARE is indicated to process, visualize and record 3D digital ultrasound images in a view to map the organ. Additional features include 2D/3D image and organ display, measurement, data management, multimodal image fusion (ultrasound, MRI, etc.). Patient population: all patients requiring an ultrasound scan or ultrasound-based intervention particularly in urology.

TRINITY is an electro medical system considered as a system composed of: - A mobile workstation composed by a central unit with ultrasound beamformer, a tactile . screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart. Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse. - Ultrasonic probe: 2D/3D end-fire endocavity probe. Optionally 2D probes can be delivered: linear probe and abdominal probe. - 3D PROSTATE SUITE PROMAP software composed of the base software and PROMAP –Ty that drives the ultrasound module and perform additional measuring functions. The system generates ultrasound waves in the low megahertz range, typically from 1 Mhz to 20 Mhz. Two main ultrasound modes are provided by the system: B-mode imaging for structural analysis and Doppler imaging for body fluid flow analysis. - B-mode imaging measures the time and waveform differences between wave emission and . wave reception to reconstruct an image. - . Doppler imaging uses in addition the Doppler Effect to show flow direction and to inform about relative velocity (no measurement). The system also provides 3D B-mode imaging for high quality ultrasound acquisition of anatomical volumes. The technology employed is volume-swept 3D ultrasound. The clinician can control acoustic output intensity with the TI and MI indices provided by the system. They indicate the level of thermal and mechanical stress that the system causes to the tissues, allowing the clinician to apply an ALARA-principle based exposure reduction strategy.

The reusable guide is intended to provide physicians a tool for performing needle/instrument guided procedures with the use of the ultrasound endocavity transducer. The guide is attached over the endocavity transducer/probe/scanhead instruments. This device provides a fixed path for the needle or the instrument that when coupled by the ultrasound system software corresponds to on-screen imaging guidelines for visualizing guided instrument placement procedures. KOELIS endorectal ultrasound guides are supplied cleaned and are reusable. The reusable guide is dedicated for transrectal diagnosis ultrasound needle /instrument guided procedure.

The reusable guide is designed to be clipped onto an ultrasonic endocavity probe, to guide a needle along the said probe, and to be cleaned and re-sterilized after use.

UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is a computer-based software application intended to process, visualize and record 3D digital ultrasound images of the prostate. UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of the prostate gland and for the 3D transrectal ultrasound based fusion of multiple imaging modalities (ultrasound, MRI) in order to map such prostate gland. Additional software features include patient data management, multimodal data communication, multiplanar reconstruction, surface and volume rendering, organ delineation, region of interest delineation, 3D image registration and data reporting.

UROSTATION - 3D PROSTATE SUITE is a computer-based software application designed to process, visualize and record 3D digital ultrasound images of the prostate, and to manage patient and clinical data in the context of transrectal prostate biopsy. Software options provide the fusion of 3DTRUS with MRI or with other 3DTRUS modalities. Hardware Platform and Operating System The application runs on a standard Personal Computer under Microsoft Windows® operating system (version 7 or higher). Peripheral and accessories The application is controlled by a footswitch and manual input devices (mousc, kevboard), It is designed to work in connection with commercially available 3D ultrasound scanners with Ethernet connection, 3D transrectal ultrasound probe and needle guide. Software Features UROSTATION - 3D PROSTATE SUITE implements image fusion and display algorithms to provide 3D representation of prostate biopsies. A typical workflow enables the physician to intraoperatively visualize the 3D mapping of biopsies with respect to a 3DTRUS reference image of the patient's prostate. For that purpose. 3D digital images may be transferred at any time from the 3D ultrasound scanner to the Urostation for registration and display, while the physician keeps track of the organ on the ultrasound scanner using the usual 2D live B mode. Optionally, MRI/3DTRUS fusion allows the elastic registration of the 3DTRUS reference image with other imaging modalities (MRI here) in order to display the 3D biopsy mapping on multiple imaging modalities. Optionally, Second Look 3DTRUS Fusion allows the elastic registration of the 3DTRUS reference image with a previously acquired 3DTRUS reference image of the same patient in order to superimpose two 3D biopsy mappings on a unique 3DTRUS reference image. Alternatively, UROSTATION - 3D PROSTATE SUITE also provides a review mode that allows the mapping of histologic results on the said 3D reference image of the patient's prostate. Patient information, images and 3D biopsy mapping may be stored or printed for future retrieval and examination.

UROSTATION - 3D PROSTATE SUITE is a computer-based software application intended to process, visualize and record 3D digital ultrasound images of the prostate. UROSTATION - 3D PROSTATE SUITE is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multi-planar reconstruction and 3D image registration.

UROSTATION - 3D PROSTATE SUITE is a computer-based software application designed to process, visualize and record 3D digital ultrasound images of the prostate, and to manage patient and clinical data in the context of transrectal prostate biopsy.