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510(k) Data Aggregation

    K Number
    K232166
    Device Name
    PreXion3D Expedition
    Manufacturer
    PreXion Corporation
    Date Cleared
    2023-09-08

    (49 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PreXion Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreXion3D Expedition is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height: these height and weight measurements approximately correspond to that of an average 5 year old.
    Device Description
    PreXion3D Expedition consists of a scanner, which is used for generating X-ray and detecting image data, and a console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating crosssection diagram, etc.), and output the image to a printer. X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, Panoramic scan) and Cephalometric Scan.
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    K Number
    K222150
    Device Name
    PreXion3D Expedition
    Manufacturer
    PreXion Corporation
    Date Cleared
    2023-01-12

    (176 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PreXion Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreXion3D Expedition is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
    Device Description
    PreXion3D Expedition consists of a scanner, which is used for generating X-ray and detecting image data, and a console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating crosssection diagram, etc.), and output the image to a printer. X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, Panoramic scan) and Cephalometric Scan.
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    K Number
    K221525
    Device Name
    PreXion3D Explorer PRO
    Manufacturer
    PreXion Corporation
    Date Cleared
    2022-07-22

    (57 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PreXion Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreXion3D Explorer PRO is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
    Device Description
    PreXion3D Explorer PRO consists of a scanner, which is used for generating X-ray and detecting image data, and a console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating crosssection diagram, etc.), and output the image to a printer. X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, Panoramic scan) and Cephalometric Scan.
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    K Number
    K203784
    Device Name
    PreXion3D Explorer PRO
    Manufacturer
    PreXion Corporation
    Date Cleared
    2021-02-23

    (57 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PreXion Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreXion3D Explorer PRO is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
    Device Description
    PreXion3D Explorer PRO consists of a scanner, which is used for generating X-ray and detecting image data, and a console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating crosssection diagram, etc.), and output the image to a printer. X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, CT-Panoramic scan) and Cephalometric Scan.
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    K Number
    K193329
    Device Name
    PreXion3D Explorer EX
    Manufacturer
    PreXion Corporation
    Date Cleared
    2020-04-09

    (129 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PreXion Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreXion3D Explorer EX is intended to produce two-dimensional digital x-ray images including panoramic image and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old. Use of equipment and exposure settings designed for adults of average size can result in excessive radiation exposure for a smaller patient. Studies have shown that pediatic patients may be more radiosensitive than adults (i.e., the cancer risk per unit dose of ionizing radiation is higher), and so unnecessary radiation exposure is of particular concern for pediatric patients.
    Device Description
    PreXion3D Explorer EX consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explorer EX Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan) and the tomographic image (CT scan, CT-Panoramic scan, Panoramic Scan).
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    K Number
    K190320
    Device Name
    PreXion3D Explorer
    Manufacturer
    PreXion Corporation
    Date Cleared
    2019-04-15

    (61 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PreXion Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreXion3D Explorer is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
    Device Description
    PreXion3D Explorer consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explorer Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. X-ray image data is acquired while the rotation around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, CT-Panoramic scan) and Cephalometric Scan.
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    K Number
    K181983
    Device Name
    PreXion 3D Excelsior
    Manufacturer
    PreXion Corporation
    Date Cleared
    2018-08-17

    (23 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PreXion Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreXion 3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital X-ray images of the dental (oral), maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment.
    Device Description
    PreXion 3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.
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    K Number
    K173878
    Device Name
    PreXion3D Excelsior
    Manufacturer
    PreXion Corporation
    Date Cleared
    2018-01-19

    (29 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PreXion Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment.
    Device Description
    PreXion3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.
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    K Number
    K161881
    Device Name
    PreXion3D Excelsior
    Manufacturer
    PreXion Corporation
    Date Cleared
    2016-10-03

    (87 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PreXion Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreXion3D Excelsior is intended to produce two dimensional digital panoranic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand wrist to obtain carpus innages for growth and maturity assessment.
    Device Description
    PreXion3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.
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