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510(k) Data Aggregation

    K Number
    K250664
    Device Name
    Navigo Workstation 2.3 (FPRMC00039)
    Manufacturer
    Date Cleared
    2025-08-07

    (155 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    UC-CARE Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K173054
    Device Name
    Navigo Workstation Version 2.0
    Manufacturer
    Date Cleared
    2018-01-16

    (110 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    UC-Care Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UC-Care Navigo Workstation is an adjunctive tool for ultrasound guided procedures and is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. The Navigo Workstation offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other. It also provides the ability to display a simulated image of a tracked insertion tool such as a needle, guide wire, catheter, grid plate or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration, as well as storage and future retrieval of this information. Navigo is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers.
    Device Description
    The Navigo Workstation Version 2.0 is an adjunctive tool in the management of prostate diagnostic and interventional procedures. The Navigo Workstation Version 2.0 allows prostate needle tracking, recording, and management solution. The Navigo Workstation Version 2.0 is designed to assist the physician in performing prostate diagnostic and interventional procedures by providing regional orientation information, displaying a 3D model with real-time tracking and recording of the needle location. The Navigo Workstation Version 2.0 offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other. The device includes means to compensate for patient body and prostate motion at any time during the procedure. The Navigo Workstation Version 2.0 is designed to work with standard trans-rectal / transperineal ultrasound systems and biopsy setup without changing or interfering with the physician's existing workflow. The Navigo Workstation Version 2.0 connects to the video output of the ultrasound system and by tracking the ultrasound probe's position, the recorded 2D ultrasound images are transferred to the Navigo Workstation Version 2.0 for viewing and creation of a 3D model. As with any other procedure, the US probe is used together with a standard disposable cover sheath supplied by the user. Two dimensional (2D) images and the 3D model of the prostate are displayed on the Navigo Workstation Version 2.0's screen. The Navigo Workstation Version 2.0 is equipped with tools to manipulate (rotate, pan, zoom) the model, and to archive and retrieve the information for further use. The tracking and recording enables display of an accurate 3D model of the prostate and to record needle locations on the model. Pathology diagnosis results may be updated on the 3D model and a color display representation provides a visual display of the pathology results. The Navigo Workstation Version 2.0 supports the display of ROIs on the 3D model and displays visual indication when the needle trajectory intersects with an ROI (Region Of Interest) is defined by the physician by segmenting a portion of the prostate on a 2D image and displaying its location on the 3D model, thereby defining a portion of the prostate as a target to direct a needle within. The 2D images for segmentation of the ROI can be either a frozen Ultrasound image or a DICOM compliant image from another imaging study completed prior to the Ultrasound procedure (e.g. MR,CT).The ROls are clearly numbered and labeled by a letter symbolizing its origin (Ultrasound or DICOM). On each image, more than one ROI may be defined (segmented). The live 2D ultrasound image is superimposed in real-time with the 2D ROI boundaries thus allowing the physician to see the real-time advancement of the needle on the live ultrasound image with reference to ROI boundaries. The 3D model is displayed on a separate window alongside the ultrasound's live continuous images display, allowing prostate 3D orientation. Regardless of the type of ultrasound probe used for the procedure (side-fire or end-fire) a cannula for a needle is built within the outer shell of the probe and therefore a needle can be inserted through the designated cannula. The designated cannula defines the needle path along its trajectory. The needle trajectory is displayed on the 3D model representing the potential needle route to allow the physician to direct the needle in real time into the target. When the projected path intersects with an ROI, the ROI will change indicating the needle can be directed inside the ROI if the physician ensures that the needle is inserted deep enough. In trans-perineal procedures the grid-plate sensor is placed on the grid base via a fixator; the sensor tracks the grid location during the procedure and enables the Navigo Workstation Version 2.0 to present in real time the optional trajectories locations. During the procedure, the physician may change some of the parameters on the US system or perform different actions that require the Navigo Workstation Version 2.0 to adjust. A physician may wish to freeze an image and perform measurements, label the image and save it to the report, switch between transversal and longitudinal view, or change the view of the ultrasound image. The Navigo Workstation Version 2.0 is equipped with image state algorithms to automatically detect the change in parameters and adjust itself to the new parameters. For example, if the physician freezes the US image, the Navigo Workstation Version 2.0 will automatically present additional menu option for a frozen image like measurements tools and labeling. The image state algorithm was developed to support generic ultrasound parameters and is specifically tested for each new ultrasound system model the Navigo Workstation Version 2.0 is required to support. In case of auto-detection failure, the user is informed and asked to confirm or manually change the detected parameters In order to continue. In off-line mode, the Navigo Workstation Version 2.0 software further enables the physician to analyze previous procedures using the prostate model, update the 3D model if necessary. update the recorded biopsies' locations, generate reports, and provides a DICOM (MRI/CT) interface for ROI definition, 3D model display, and data communication.
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    K Number
    K160934
    Device Name
    UC-CARE NaviGo Workstation
    Manufacturer
    Date Cleared
    2017-02-06

    (308 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    UC-CARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UC-CARE NaviGo Workstation is an adjunctive tool for ultrasound guided procedures and is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. The NaviGo™ Workstation offers the ability to fuse DICOM originated information (e.g. MRI) with the ultrasound images and thus superimpose information from one modality onto the other. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration. The device is specifically indicated to provide information within the prostate to assist needle targeted procedures (e.g. biopsy) regions of interest display, procedures planning and, reconstruction of a 3D rendered surface model of the prostate display needle locations that have been selected by the physician, as well as storage and future retrieval of this information.
    Device Description
    The NaviGo™ Workstation is an adjunctive tool in the management of prostate diagnostic and interventional procedures. The NaviGo™ Workstation allows prostate needle tracking, recording, and management solution. The NaviGo™ Workstation is designed to assist the physician in performing prostate diagnostic and interventional procedures by providing regional orientation information, displaying a 3D model with real-time tracking and recording of the needle location. The NaviGo™ Workstation offers the ability to fuse DICOM originated information (e.g. MRI) with the ultrasound images and thus superimpose information from one modality onto the . The device includes means to compensate for patient body and prostate motion at any time during the procedure. The NaviGo™ Workstation is designed to work with standard trans-rectal ultrasound systems and biopsy setup without changing or interfering with the physician's existing workflow. The NaviGo™ Workstation connects to the video output of the ultrasound system and by tracking the ultrasound probe's position, the recorded 2D ultrasound images are transferred to the NaviGo™ Workstation for viewing and creation of a 3D model. As with any other procedure, the TRUS probe is used together with standard disposable cover sheath supplied by the user. Two dimensional (2D) images and the 3D model of the prostate are displayed on the NaviGo™ Workstation's screen. The NaviGo™ Workstation is equipped with tools to manipulate (rotate, pan, zoom) the model, and to archive and retrieve the information for further use. The tracking and recording enables display of an accurate 3D model of the prostate and to record needle locations on the model. Pathology diagnosis results may be updated on the 3D model and a color display representation provides a visual display of the biopsy results. The NaviGo™ Workstation supports the display of ROIs on the 3D model and displays visual indication when the needle trajectory intersects with an ROI (region of interest) is defined by the physician by segmenting a portion of the prostate on a 2D image and displaying its location on the 3D model, thereby defining a portion of the prostate as a target to direct a needle within. The 2D model for segmentation of the ROI can be either an Ultrasound image frozen during the procedure or a DICOM complaint image from another imaging study completed prior to the Ultrasound procedure (e.g. MR) when selecting the fusion procedure to display the planned targets. The ROIs are clearly numbered and labeled by a letter symbolizing it origin (Ultrasound or DICOM), On each image, more than one ROI may be defined (segmented). The live 2D ultrasound image is superimposed in real-time with the 2D ROI boundaries thus allowing the physician to see the real-time advancement of the needle on the live ultrasound image with reference to ROI boundaries. The 3D model is displayed on a separate window alongside the ultrasound's live continuous images display, allowing prostate 3D orientation. Regardless of the type of ultrasound probe used for the procedure (side-fire or end-fire) a cannula for a needle is built within the outer shell of the probe and therefore a needle can be inserted through the designated cannula. The designated cannula defines the needle path along its trajectory. The needle trajectory is displayed on the 3D model representing the potential needle route to allow the physician to direct the needle in real time into the target. When the projected path intersects with an RQL the color of the ROI will change indicating the needle can be directed inside the ROI if the physician ensures that the needle is inserted deep enough. During the procedure, the physician may change some of the parameters on the US system or perform different actions that require the NaviGo™ Workstation to adjust. A physician may wish to freeze an image and perform measurements, label the image and save it to the report, switch between transversal and longitudinal view, or change the view of the ultrasound image. The NaviGo™ Workstation is equipped with image state algorithms to automatically detect the change in parameters and adjust itself to the new parameters. For example, if the physician freezes the US image, the NaviGo will automatically present additional menu option for a frozen image like measurements tools and labeling. The image state algorithm was developed to support generic ultrasound parameters and is specifically tested for each new ultrasound the NaviGo™ is required to support. In off-line mode, the NaviGo™ software further enables the physician to analyze previous procedures using the prostate model, update the 3D model if necessary, update the recorded biopsies' locations, generate report, and provides a DICOM (e.g. MRI) interface for ROI definition, 3D model display, and data communication.
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    K Number
    K100784
    Device Name
    UC-CARE NAVIGO SYTEM
    Manufacturer
    Date Cleared
    2011-11-01

    (592 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    UC-CARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UC-CARE NaviGo™ Workstation is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. Additional software features to assist biopsy procedures include patient data management, multi-planar reconstruction, segmentation, image measurementand 3-D image registration. The device is specifically indicated to provide information on regional orientation within the prostate to assist biopsy procedures under standard ultrasound guidance, reconstruction of a 3D rendered surface model of the prostate and to display locations for biopsies that have been selected by the physician, as well as storage and future retrieval of this information.
    Device Description
    The Navigo™ Workstation is an aiding tool in the management of prostate procedures. The Navigo™ Workstation is designed to assist the physician to transfer and display ultrasound images on the workstation screen, build, display, and manipulate a 3D model of the prostate on screen, provide regional orientation, archive the images and the 3D model, as well as provide data management solutions. The Navigo™ Workstation enables tracking, displaying and recording of the biopsy needle trajectory location retrieved from the ultrasound probe. The Navigo™ Workstation is designed to work with standard transrectal Ultrasound system without changing or interfering with the physician's flow of work. The Navigo™ Workstation connects to the Ultrasound system and by tracking the Ultrasound probe's position, the recorded 2D Ultrasound images are transferred to the Navigo™ Workstation for viewing and 3D modeling. The 2D images and the 3D model of the prostate are displayed on the Workstation screen. The workstation is equipped with tools to manipulate (rotate, zoom, pan) the model, to add planned biopsy locations on the model and to archive and retrieve the information for further use. Pathology diagnosis results can be updated on the 3D model and a color display representation gives a visualized status of the prostate.
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    K Number
    K090978
    Device Name
    UC-CARE WARMING SYSTEM
    Manufacturer
    Date Cleared
    2009-08-10

    (126 days)

    Product Code
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    UC-CARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UC-CARE Warming System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate using cryosurgical systems that have been cleared for use on the prostate.
    Device Description
    The UCW System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate. The UCW System includes a Urethral Catheter & Tubing Set and a Warming Kt The Urethral Catheter is introduced into the bladder to outline the urethral course, and to protect the urethra during therapeutic transperineal, prostatic cryotherapy procedures. The Urethral catheter further transfers heat to the urethral tissue during cryotherapy of the prostate in order to protect the urethra from, excessive cold temperatures. The closed loop Tubing Set is connected to the catheter's inlet and outlet ports and circulates warm sterile water or saline via the Warming Kit that includes a fluid warmer and peristaltic pump.
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