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510(k) Data Aggregation

    K Number
    K250850
    Device Name
    Nanox.ARC X
    Manufacturer
    Nano-x Imaging Ltd.
    Date Cleared
    2025-04-16

    (27 days)

    Product Code
    IZF
    Regulation Number
    892.1740
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nano-x Imaging Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nanox.ARC X is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, physicists. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, angiographic, cardiac, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
    Device Description
    Nanox.ARC X is a stationary, floor-mounted, stand-alone digital tomosynthesis system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, from a single tomographic sweep. It serves as an adjunct to conventional radiography, for adult patients in recumbent positions. The system is intended for use in professional healthcare settings such as hospitals, clinics, and imaging centers by trained radiographers, radiologists, and physicists The Nanox.ARC X includes a secured, dedicated off-the-shelf handheld operator console, a multisource, tiltable arc gantry with five identical tubes, a motorized patient table, and a flat panel detector of a scintillator-photodetector type. The image reconstruction service and DICOMization services can be hosted either locally or as part of the secured Nanox.CLOUD, according to customer preference. Nanox.CLOUD also hosts a protocol database service package. The Nanox.ARC X X-ray tubes are operated sequentially, one at a time, generating multiple low-dose images acquired from different angles, during a single sweep, dividing the overall power requirements among the tubes. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions. The acquired projection imaging data is anonymized and automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis image result reduces the effect of overlying structures and provides depth information on structures of interest. The resultant images are re-identified and sent using the DICOM protocol.
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    K Number
    K242395
    Device Name
    Nanox.ARC
    Manufacturer
    Nano-x Imaging Ltd.
    Date Cleared
    2024-12-04

    (113 days)

    Product Code
    IZF, MQB
    Regulation Number
    892.1740
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nano-x Imaging Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nanox.ARC is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, cardiac, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
    Device Description
    Nanox.ARC is a stationary, floor-mounted, stand-alone digital tomosynthesis system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, from a single tomographic sweep. It serves as an adjunct to conventional radiography, for adult patients in recumbent positions. The system is intended for use in professional healthcare settings such as hospitals, clinics, and imaging centers by trained radiologists, and physicists. The Nanox.ARC includes a secured, dedicated off-the-shelf handheld operator console, a multisource, tiltable arc gantry with five identical tubes, a motorized patient table, and a flat panel detector type. The image reconstruction service and DICOMization services can be hosted either locally or as part of the secured Nanox.CLOUD, according to customer preference. Nanox.CLOUD also hosts a protocol database service package. The Nanox.ARC X-ray tubes are operated sequentially, one at a time, generating multiple low-dose images acquired from different angles, during a single sweep, dividing the overall power requirements among the tubes. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions. The acquired projection imaging data is anonymized and automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis reduces the effect of overlying structures and provides depth information on structures of interest. The resultant images are re-identified and sent using the DICOM protocol.
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    K Number
    K222934
    Device Name
    Nanox.ARC
    Manufacturer
    Nano-X Imaging Ltd.
    Date Cleared
    2023-04-28

    (214 days)

    Product Code
    IZF, MQB
    Regulation Number
    892.1740
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nano-X Imaging Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists. Digital Tomosynthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, cardiac, pulmonary, intra-abdominal, intra-cranial, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
    Device Description
    Nanox.ARC is a tomographic and solid-state X-ray system (product codes IZF and MQB) intended to produce tomographic images of the human musculoskeletal system from a single tomographic sweep, as an adjunct to conventional radiography, on adult patients. Nanox.ARC is a floor-mounted tomographic system that consists of a user control console, a multisource, tiltable arc gantry with five alternately-switched tubes, a motorized patient table, a flatpanel detector of a scintillator-photodetector type, and Protocols database and Image processing software packages. Nanox.ARC utilizes several small-sized X-ray tubes that are independently and electronically switched, thereby dividing the overall power requirements over multiple tubes. Nanox.ARC utilizes a tilting imaging ring with five X-ray tubes, operated sequentially, one at a time, used to generate multiple low-dose X-ray projection images acquired from different angles during a single spherical (non-linear) sweep. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions. The acquired projection imaging data is automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis image result reduces the effect of overlying structures and provides depth information on structures of interest. The image reconstruction service, as well as the system's protocol database and DICOMization services, can be hosted either locally or as part of the Nanox.CLOUD, according to customer preference. The resultant images are sent using the DICOM protocol.
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    K Number
    K203782
    Device Name
    Nanox Cart X-ray System
    Manufacturer
    Nano-x Imaging Ltd.
    Date Cleared
    2021-04-01

    (94 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nano-x Imaging Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is intended as an X-Ray source for diagnosis. Operators of the Nano-x Cart X-Ray System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed. Indication for Use – The device is designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients. Limitations for use – This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, angiographic, interventional, or fluoroscopic applications. This device is not intended for pediatric use.
    Device Description
    The Nanox Cart X-Ray system is a mobile X-Ray system designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients. The system facilitates X-ray examinations in situations where it is not possible to transport the patient to a ward with fixed equipment. The Nanox Cart X-Ray system consists of a mobile system enclosure; an X-Ray tube assembly consists of the X-ray Tube, Cooling Fluid, electronics, and casing; a pulse generator and a highvoltage generator; a microprocessor that provides increased exposure consistency and efficient operation; and a touch-based screen LCD which provides a simple and user-friendly interface and technique selection. The Nanox Cart is specified and designed to operate only with a Flat Panel Digital X-ray Detector Model EVS3643, manufactured by DRTECH Inc. (K162552) The intended operators of the Nanox Cart X-ray System are healthcare professionals familiar with and responsible for the X-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, the Nanox Cart X-ray System adheres to recognized and established industry practices and standards.
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