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510(k) Data Aggregation

    K Number
    K243432
    Device Name
    Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
    Manufacturer
    Brainlab AG
    Date Cleared
    2025-07-22

    (259 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250660
    Device Name
    LUMINOS Q.namix T; LUMINOS Q.namix R
    Manufacturer
    Siemens Medical Solutions
    Date Cleared
    2025-07-14

    (131 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251520
    Device Name
    Cios Alpha; Cios Flow
    Manufacturer
    Siemens Medical Solutions USA, Inc
    Date Cleared
    2025-07-09

    (54 days)

    Product Code
    OWB, JAA, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243884
    Device Name
    TAVIPILOT
    Manufacturer
    Caranx Medical
    Date Cleared
    2025-07-07

    (201 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250010
    Device Name
    EXTRON 3; EXTRON 5; EXTRON 7
    Manufacturer
    DRTECH Corporation
    Date Cleared
    2025-06-10

    (159 days)

    Product Code
    OWB, JAA, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EXTRON Series are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine (※ This device is not intended for mammography applications.)
    Device Description
    EXTRON Series are mobile fluoroscopic X-ray systems with high output capacity, high thermal capacity, and high-resolution image processing systems that provide X-ray images of the patient's anatomical structures during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. The EXTRON Series are composed of a C-arm main body and a monitor cart. The C-arm main body is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and an XConsoleOP program, while the monitor cart is composed of a monitor, a thermal transfer printer, a mouse, a keyboard and an XConsole program. The operating principle of the device is designed to expose the patient to X-ray beams. The range of X-ray irradiation are adjusted by the collimator. X-rays can penetrate into the human body through a two-step conversion process. X-ray photons are converted into light. The light is then converted into electrical signals through the sensor. The electrical charges are transmitted as the sensor output and converted into signals. These signals are digitized and captured by memory. The captured images are processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device, such as a network printer.
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    K Number
    K243411
    Device Name
    Diagnostic X-ray System
    Manufacturer
    Nanjing Perlove Medical Equipment Co., Ltd.
    Date Cleared
    2025-05-19

    (199 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diagnostic X-ray System is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
    Device Description
    The Diagnostic X-ray System is a mobile (within an imaging facility) general-purpose diagnostic fluoroscopic X-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. The Diagnostic X-ray System is consists of X-ray source assembly (combined type), collimator, flat-panel detector, image processing workstation, C-arm and mobile rack, Medical Image Workstation Software.
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    K Number
    K242731
    Device Name
    MasteRad MiniX Mobile Digital Imaging System (Mini-X)
    Manufacturer
    Medicatech USA Inc.
    Date Cleared
    2025-05-16

    (248 days)

    Product Code
    OWB, JAA, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mini-X is intended for use by qualified/trained medical professionals who fully understand the safety information, emergency procedures, and the device's capabilities and function. The device provides fluoroscopic imaging and is used for guidance and visualization during diagnostic radiography and surgical procedures of the extremities. The device will be used in healthcare facilities inside and outside the hospital, using various methods for the extremities on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in a prone or supine position. The system is not intended for mammography applications. (Rx Only)
    Device Description
    The Mini-X system, a unique mobile imaging system, can acquire, process, and display fluoroscopic images. Its portability allows for easy positioning within a room and movement from room to room within a facility, facilitating on-demand fluoroscopic examinations. The system's innovative design incorporates a low-powered mono-block generator and a dynamic flat-panel detector, enabling it to be powered through a single-phase 120VAC power outlet. The Insight Enhanced™ DRF Digital Imaging System, a cutting-edge tool for healthcare professionals, offers full control over the imaging chain. It empowers the operator to view and enhance high-definition fluoroscopy images up to 30 fps, bringing out diagnostic details that are challenging or impossible to see using conventional imaging techniques. The system's versatility is demonstrated by its ability to store images locally for short-term storage, produce hardcopy images with a laser printer, or send images over a network for longer-term storage. Its primary components, including a dynamic flat panel detector, monitors, and an image processor PC, underscore its comprehensive and advanced capabilities.
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    K Number
    K250282
    Device Name
    Persona C HR
    Manufacturer
    A.T.S. Applicazione Tecnologie Speciali s.r.l.
    Date Cleared
    2025-04-30

    (89 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. PERSONA C HR device can be used on all patients, except pediatric patients, within the limits of the device. Examples of clinical applications could be Orthopedic surgery, General surgery, Cardiac procedures, Thoracic surgery, Vascular procedures, Pain therapy and Urological procedures.
    Device Description
    PERSONA C HR is a C-arm mobile unit with flat panel detector. It allows imaging under the following modes: - Low Dose Fluoroscopy, - High Quality Fluoroscopy, - High Quality + Fluoroscopy - Digital radiography (Snapshot), - Fluoroscopy in Road Mapping mode (optional), - Fluoroscopy in DSA mode (optional). It is provided with a 30x30 cm Flat Panel detector and a 25 kW X-ray generator. The unit is composed of: Monitor unit, Stand with c-arm, X-ray commands, Printer (optional). The device acquires images employing X-rays emitted by an X-ray source which can produce up to 25kW. The unit, which is powered by a single-phase electrical supply, generates ionizing radiations (X-rays) which, as they pass through the patient, reach a flat panel detector that produces radiological images. An x-ray collimator, placed on the monobloc, is responsible for limiting the emission beam of ionizing radiation. The images collected by the detector are sent to a video processor, which, after processing the information received, allows radiological images to be displayed on the display monitor.
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    K Number
    K243376
    Device Name
    uAngio AVIVA CX
    Manufacturer
    Shanghai United Imaging Healthcare Co.,Ltd.
    Date Cleared
    2025-04-28

    (180 days)

    Product Code
    OWB, JAA
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The system is used to perform image guidance in diagnostic, intervention and surgical procedures. Procedures that can be performed with the system include cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography and whole body radiographic/fluoroscopic procedures.
    Device Description
    The uAngio AVIVA CX is an angiographic X-ray system that generates X-rays through the X-ray tube, receives the signal through the flat panel detector and presents the image after D/A conversion and image post-processing. The uAngio AVIVA CX is designed to provide intelligent, safe, and precise image guidance in cardiac, neuro, oncology, peripheral interventional, and surgical procedures. The main components of the uAngio AVIVA CX include a C-arm stand, patient table, generator, X-ray tube, flat panel detector, collimator, grid, monitors, control module, control panel, foot switch, hand switch, V-box, and intercom. The main software characteristics of the uAngio AVIVA CX include patient registration, patient administration, 2D&3D image viewing and post-processing, data import/archiving, filming, camera-assisted recognition function (uSpace), and voice control function (uLingo).
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    K Number
    K234067
    Device Name
    ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
    Manufacturer
    medPhoton GmbH
    Date Cleared
    2025-03-28

    (462 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ImagingRing m is a mobile x-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The ImagingRing m provides an interface that can be used by system integrators for integration of the ImagingRing m with image guidance systems such as surgical navigation systems.
    Device Description
    The ImagingRing m (Version 2.0) is from a technical point of view the same system as its already approved predecessor ImagingRing m (K203281). The only difference is the implementation of a new x-ray source in combination with a software upgrade, which allows for higher power settings. The ImagingRing m functions as a mobile x-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The ImagingRing m (Version 2.0) provides an interface that can be used by system integration of the ImagingRing m (Version 2.0) with image guidance systems such as surgical navigation systems. The ImagingRing m (Version 2.0) consists of the ring gantry and respective arms carrying the X-Ray source and directly integrates all necessary electronic and components along with low-level software to realize coordinated motion and X-ray emission in the device's ring carrier and legs. The ImagingRing m (Version 2.0) device also provides a detachable Remote Control Panel (RCP) component that provides a display and controls elements such that users can interact with the machine.
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