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510(k) Data Aggregation

    K Number
    K243681
    Device Name
    Neuro Insight V1.0
    Manufacturer
    Olea Medical S.A.S.
    Date Cleared
    2025-07-23

    (236 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    LLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250716
    Device Name
    IMAGE ONE
    Manufacturer
    Infomed Software, S.L.
    Date Cleared
    2025-07-23

    (135 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    LLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250686
    Device Name
    GyriCalc (Version 1.0.0)
    Manufacturer
    NeuroSpectrum Insights Corp.
    Date Cleared
    2025-07-22

    (138 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    LLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250181
    Device Name
    AV Viewer
    Manufacturer
    Philips Medical Systems Nederland B.V.
    Date Cleared
    2025-07-15

    (174 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    LLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250120
    Device Name
    GECHO
    Manufacturer
    Narnar, LLC
    Date Cleared
    2025-07-14

    (179 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    LLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251863
    Device Name
    CustomSurg OrthoPlanner
    Manufacturer
    CustomSurg AG
    Date Cleared
    2025-07-07

    (20 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    LLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243666
    Device Name
    uOmniscan
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2025-06-17

    (202 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    LLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    uOmniscan is a software application for providing real-time communication between remote and local users, providing remote read-only or fully controlled access to connected medical imaging devices, including the ability to remotely initiate MR scans. It is also used for training medical personnel in the use of medical imaging devices. It is a vendor-neutral solution. Access must be authorized by the onsite user operating the system. Images reviewed remotely are not for diagnostic use.
    Device Description
    uOmniscan is a medical software designed to address the skill differences among technicians and their need for immediate support, allowing them to interact directly with remote experts connected to the hospital network. By collaboration between on-site technicians and remote experts, it enables technicians or radiologists located in different geographic areas to remotely assist in operating medical imaging devices. uOmniscan provides healthcare professionals with a private, secure communication platform for real-time image viewing and collaboration across multiple sites and organizations. uOmniscan establishes remote connections with Modality through application, KVM (Keyboard, Video, Mouse) switch, or UIH's proprietary access tool uRemote Assistant. The connection can be made in full control or read-only mode, assisting on-site technicians in seeking guidance and real-time support on scan-related issues, including but not limited to training, protocol evaluation, and scan parameter management, with the capability to remotely initiate scans for MR imaging equipment. In addition to supporting remote access and control of modality scanners, uOmniscan also supports common communication methods including real-time video, as well as audio calls and text chats between users. Images viewed remotely are not for diagnostic purposes. It is a vendor-neutral solution compatible with existing multimodality equipment in healthcare networks, allowing healthcare professionals to share expertise and increase work efficiency, while enhancing the communication capabilities among healthcare professionals at different locations.
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    K Number
    K244012
    Device Name
    Mosaic (V1.0.1)
    Manufacturer
    Navier Medical
    Date Cleared
    2025-06-16

    (172 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    LLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mosaic V1.0.1 is a medical image analysis system that allows the viewing, processing, and analysis of multi-dimensional digital images acquired with contrast from CT imaging devices. Mosaic V1.0.1 is intended to assist trained medical professionals in the stratification of patients suspected or identified to have atherosclerosis as well as stratification of patients suspected or identified to have aneurysmal disease of the aorta or carotid, iliac, femoral and popliteal arteries. The software enables post processing of images obtained using a multidetector CT and provides tools for the measurement and visualisation of arterial vessels and any disease present, including editing of contrasted lumen and artery boundaries. Any processed artery can be selected to view: the vessel in 3D; color-coded interactive data maps displayed on the 3D vessel; curved, straightened and cross-sectional MPR views of the vessel; and quantitative data from regions of interest. Data includes standard 2D distance measurements as well as stenosis, Hounsfield unit statistics, and tissue volumes. Typical users of Mosaic V1.0.1 outputs are trained medical professionals, including radiologists and clinicians. Typical operators of Mosaic V1.0.1 are those suitably trained in the use of the software. Mosaic V1.0.1 is intended to complement standard of care but is not intended to provide a diagnosis or clinical recommendation.
    Device Description
    Mosaic V1.0.1 is a post-processing tool used to analyse arterial diseases. It reads in computed tomography angiography (CTA) scans and users can process the scans to aid clinicians in their analysis of anatomy and pathology. Processing CTA with Mosaic enables the creation of vessel centrelines from which measurements and image reformatting is possible. The outputs of the software include visual images, measures of diameter, distance, volume, including plaque volumes, positive remodelling of the arterial wall, and stenosis. These measurements are based on user segmentation. Outputs from Mosaic, including the saved analysis file and PDF report, can be used to assist with the decision-making process and clinical management of the patient, but Mosaic is not intended to be used as a sole source of clinical data to determine diagnosis and/or treatment pathways.
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    K Number
    K243703
    Device Name
    TechLive
    Manufacturer
    DeepHealth, Inc.
    Date Cleared
    2025-06-05

    (188 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    LLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TechLive is a software application intended to provide remote access for real-time image acquisition, assistance, review, monitoring and standardization of imaging devices across multiple locations. It is a vendor neutral solution allowing read-only or full access control to connected devices. TechLive is also intended for training of medical personnel working on medical imaging devices. TechLive is not intended for diagnostic use.
    Device Description
    TechLive is a software application intended to provide remote access for real-time image acquisition, assistance, review, monitoring and standardization of imaging devices across multiple locations. It is a vendor neutral solution allowing read-only or full access control to connected devices. TechLive is also intended for training of medical personnel working on medical imaging devices. TechLive is not intended for diagnostic use. Clinical users can remotely access imaging devices from a computer via a secure software connection that streams video and audio, including access to keyboard and mouse controls. This setup allows remote users to assist local in-suite assistants or other clinical users by means of audio/video connection or perform remote acquisitions themselves. Depending upon the device used to acquire the images, the remote access can allow for "view mode", to support the in-suite assistant, or "control mode", where the remote user controls the console software of the imaging device. Remote access to the local imaging device can only be granted by the local in-suite assistant and can be granted or revoked as needed using an on-premises computer installed with the assistance touch interface. "Control mode" access may be granted on-demand or prior to acquisition to access the scanner. TechLive offers a secure collaboration platform with live audio and video, enabling remote acquisition and seamless collaboration among healthcare professionals. TechLive is vendor-neutral and compatible with existing imaging devices, including Ultrasound (US), Magnetic Resonance Imaging (MRI), Computer Tomography (CT), and Positron Emission Tomography (PET/CT).
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    K Number
    K250800
    Device Name
    UroNav 4
    Manufacturer
    Philips DS North America LLC
    Date Cleared
    2025-06-05

    (83 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    LLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UroNav is a stereotaxic medical device intended to assist the clinician with planning and guidance for clinical, interventional and/or diagnostic procedures for biopsy and/or soft tissue ablation. It provides 2D and 3D visualization of Ultrasound (U/S) images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance (MR). It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, 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. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 2D/3D image registration. UroNav is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland. The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
    Device Description
    The system assists physicians in guiding interventional instruments to pre-defined targets, which may be identified pre-procedurally or intra-procedurally using imaging data or relative to a designated position on the patient. As an image fusion system, UroNav combines pre-procedural imaging, such as Magnetic Resonance Imaging (MRI), with real-time intra-procedural imaging from ultrasound (US) systems. This fusion capability enables precise localization of areas of interest detected in one imaging modality and maps them onto another. The system also facilitates spatial registration between two-dimensional (2D) and three-dimensional (3D) imaging datasets and between imaging data and physical patient space. The UroNav 4 System includes the following components: - **Electromagnetic Measurement System (EMMS):** Comprising a Field Generator, System Control Unit, and System Interface Unit(s) for electromagnetic tracking. - **System Unit:** Incorporating a central processing unit (CPU), monitor, medical-grade power supply, mobile cart, and UroNav software. - **Field Generator Stand:** Ensuring stability for electromagnetic tracking during procedures. - **Software Features:** Patient data management, multiplanar reconstruction, segmentation, image measurement tools, and 3D image registration capabilities. - **Compatible Devices:** Compatible with commercially available ultrasound machines, probes, needle guides, biopsy devices, and applicators. The system reconstructs 3D ultrasound images from live 2D video streams connected to ultrasound systems. Clinicians can select targets and navigate instruments with precision through its interactive interface, which features a keyboard, mouse, and visual display. The UroNav system supports diverse clinical environments, such as hospital operating rooms, outpatient surgery centers, ultrasound suites, and procedure rooms. The UroNav 4 design ensures compatibility with existing clinical workflows by utilizing commercially available ultrasound machines and accessories. Additional software functionalities include patient data management, multiplanar reconstruction of images, segmentation tools for enhanced visualization, image measurements, and 3D image registration. The UroNav 4 System is intended to aid physicians in performing minimally invasive diagnostic and therapeutic procedures by providing real-time image-guided navigation. It is not intended to replace physician judgment.
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