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510(k) Data Aggregation

    K Number
    K180601
    Device Name
    Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
    Manufacturer
    Villa Sistemi Medicali S.p.A.
    Date Cleared
    2018-11-02

    (240 days)

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

    Villa Sistemi Medicali S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rotograph Prime 3D and I-MAX 3D are extra-oral dental panoramic and CBCT (aka CBVT) X-ray units to take either twc dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped x-ray beam technique; both of them are well known techniques. The devices are operated and used by dentists, radiologists and other legally qualified health care professionals. They can be used with both pediatric and adult patients.
    Device Description
    Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) is a complete 3D and 2D panoramic X-ray system. It performs: 2D standard examination programs - Standard Panoramic: adult/child panoramic exam - TMJ open and closed mouth - Sinus P/A projection - Half Panoramic (left/right) - Ortho Rad Panoramic - Frontal Dentition - Low Dose Panoramic - Bitewing (Left/Right/Left and Right 3D standard examination programs - 3D Full Dentition - 3D Single Jaw (Maxillary, Mandibular) - 3D Mandibular Teeth (Frontal, Premolars and Molars) - 3D Maxillary Teeth (Frontal, Premolars and Molars) - 3D TMJ (right/left) - 3D Sinus The images are acquired by a CMOS Flat Panel detector with CsI scintillator and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device).
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    K Number
    K162190
    Device Name
    Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2017-07-06

    (336 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILLA SISTEMI MEDICALI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rotograph Prime and I-MAX are extra-oral dental panoramic X-ray units to radiograph teeth, jaw and oral structures. The devices are operated and used by dentists, radiologists and other legally qualified health care professionals. They can be used with both pediatric and adult patients.
    Device Description
    Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is a complete panoramic X-ray system. The basic version performs: - -Panoramic adult or child exams, with 3 sizes and 3 tvpes of biting for a total of 18 combinations with automatic parameter selection; with manual selection, it is possible to select a high voltage between 60kV and 70kV, in 2kV steps and anodic current from 2 mA to 7.1 mA in the R20 scale steps. - -Sinus mode to take exams of the paranasal sinuses with front projection (postero/anterior); - -TMJ (closed/open mouth) exams in lateral projection. XP (Extended Projection Package) optional function allows to carry out the following additional exams: - -Right or left half-panoramic, to be used when the patient is known to have a problem only on one side of the arch, in order to reduce radiation; - -Low dose Panoramic, which reduces the dose radiated by excluding the TMJ's ascending rami from the radiograph; - Frontal dentition, for a radiograph of the front part (roughly from canine to canine); - - -Ortho Rad Panoramic which reduces teeth overlap, thereby improving the diagnosis of interproximal decay: - Bitewing left or right for lateral dentition (generally from eighth to fourth) with a trajectory that reduces teeth overlap; - -Bilateral Bitewing (left and right), which sequentially performs both bitewings, showing them on the same image. The images are acquired by a CCD sensor and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device). In particular, Rotograph Prime is equipped with a PAN sensor: it is suitable for Panoramic-type imaging, all Panoramic, i.e. all images with about 14cm-high field; all Panoramic. TMJ, and Sinus images belong to this type.
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    K Number
    K130109
    Device Name
    ENDOGRAPH DC
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2013-08-01

    (197 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILLA SISTEMI MEDICALI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endograph DC is an extraoral source x-ray unit for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals. It can be used with both pediatric and adult patients.
    Device Description
    Endograph DC is an extraoral source x-ray unit. Endograph DC is dedicated to intraoral radiography in which the x-ray source is placed outside the mouth of the patient while the image detector (film or digital detector) is placed inside the mouth. The image detector is not part of Endograph DC system, so it is not part of this submission.
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    K Number
    K111152
    Device Name
    ROTOGRAPH EVO 3D
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2011-07-22

    (88 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILLA SISTEMI MEDICALI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rotograph EVO 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specially for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dento maxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified healthcare professionals.
    Device Description
    Rotograph EVO 3D is a panoramic x-ray system utilizing digital imaging. It can be equipped with a cephalostat. The device can be equipped with accessories to fulfil different diagnostic needs. The images are acquired by a flat panel detector and are displayed on a monitor, and image processing, manipulation, archiving, communication and 3D reconstruction (starting from cross-sectional images taken using CBVT (Cone Beam Volumetric Tomography) technique)) are performed via a computer.
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    K Number
    K090749
    Device Name
    ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2009-05-18

    (59 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILLA SISTEMI MEDICALI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rotograph EVO and Rotograph EVO D, panoramic x-ray imaging system with cephalostat, are extraoral source x-ray system, which are intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry.
    Device Description
    Rotograph EVO and Rotograph EVO D are conventional panoramic x-ray system utilizing either films and cassettes (Rotograph EVO) or digital imaging (Rotograph EVO D). Both models can be equipped with a cephalostat. The device can be equipped with accessories to fulfil different diagnostic needs. In digital configuration (Rotograph EVO D) the images are acquired by a CCD sensor and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device).
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    K Number
    K080859
    Device Name
    DRF 4343
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2008-06-04

    (69 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILLA SISTEMI MEDICALI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use.
    Device Description
    The DRF 4343 is Intended to capture digital images from a radiographic/fluoroscopic system through a dynamic digital flat panel, to digitalize, archive and review images and to provide a network connection via DICOM protocol to various output (e.g. hardcopy, softcopy and archive) devices which uses a device.
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    K Number
    K050190
    Device Name
    APOLLO
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2005-03-25

    (57 days)

    Product Code
    KXJ, IXL, KPW
    Regulation Number
    892.1980
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILLA SISTEMI MEDICALI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.
    Device Description
    Remote controlled radiology table, collimator and spot film device
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    K Number
    K030634
    Device Name
    ENDOS DC
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2003-07-21

    (144 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILLA SISTEMI MEDICALI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
    Device Description
    extra oral source X-ray system for dental radiographic examination of the teeth
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    K Number
    K030185
    Device Name
    ENDOS AC/ACP
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2003-03-11

    (49 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILLA SISTEMI MEDICALI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
    Device Description
    ENDOS AC – ENDOS ACP intraoral system
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    K Number
    K002432
    Device Name
    STRATO X
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2000-09-01

    (24 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILLA SISTEMI MEDICALI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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