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510(k) Data Aggregation

    K Number
    K061284
    Device Name
    I-CAT SCANNER
    Manufacturer
    IMAGING SCIENCES INTL., INC.
    Date Cleared
    2006-07-03

    (56 days)

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

    IMAGING SCIENCES INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
    Device Description
    The i-CAT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The i-CAT Scanner can measure distances and thickness on two dimensional images. Images produced by the i-CAT Scanner can be printed or exported on magnetic and optical media. The i-CAT Scanner gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector, transforms them into three dimensional images and displays them on the workstation monitor for viewing.
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    K Number
    K051980
    Device Name
    DVT SCANNER
    Manufacturer
    IMAGING SCIENCES INTL., INC.
    Date Cleared
    2005-08-19

    (29 days)

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

    IMAGING SCIENCES INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imaging Sciences International Inc. DVT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The DVT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The DVT Scanner is optimized for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, the maxillofacial complex, temporal bone, etc.
    Device Description
    The DVT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional that aod a boo adgrounde and produces two dimensional views of this volume. The matix of the oxamined stances and thickness on two dimensional images. Images produced by the DVT Scanner can be printed or exported on magnetic and optical media. The DVT Scanner gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector, sonward. The bormal images and displays them on the workstation monitor for viewing.
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    K Number
    K041078
    Device Name
    SURGPLAN AND PANPLAN
    Manufacturer
    IMAGING SCIENCES INTL., INC.
    Date Cleared
    2004-12-23

    (241 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMAGING SCIENCES INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgPLAN and PanPLAN are Software packages that scan film using optical scanner or Direct Digital Capture using Solid State Sensors (from the Sensor) and store images produced by Imaging Sciences International's (or other manufacturer's) Tomographic, Panoramic and Cephlometric imaging machines. Additionally, the software has the ability to import DICOM images from volumetric data sets for analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of the imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.
    Device Description
    SurgPLAN / PanPLAN is a comprehensive software package that can scan films or certain solid state detectors, read DICOM images or DICOM volumetric data sets and display the images for the practitioner to perform analysis, measurements and surgical demonstrations for dental implants.
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    K Number
    K001248
    Device Name
    MULTI-PULSE 2000
    Manufacturer
    IMAGING SCIENCES INTL., INC.
    Date Cleared
    2000-05-04

    (16 days)

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

    IMAGING SCIENCES INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991518
    Device Name
    PANATOME
    Manufacturer
    IMAGING SCIENCES INTL., INC.
    Date Cleared
    1999-06-18

    (49 days)

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

    IMAGING SCIENCES INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imaging Sciences International Inc. Panatome Imaging system is a multifunction computer controlled Tomographic X-Ray device for taking radiographs of the head and neck region. This device has the ability to provide panoramic and pluridirectional Tomographic images. The operators manual describes the computerized operator interface for selecting and executing the various radiographic procedures. The panoramic function of this unit produces the same standard panoramic image as numerous other units in use for past several decades. The tomographic function is also similar to other units in use for past few decades, except it employs complex motion to produce tomographic slices as opposed to more commonly used linear motion. Slices produced by a complex tomographic motion are superior and more accurate as compared to linear slices. Complex motion has been used by a few other units in the recent past. Tomographic imaging is commonly used for TM Joint studies, mandible & maxilla for implant planning, sinuses, etc.
    Device Description
    The Imaging Sciences International Inc. Panatome is a free standing Tomographic X-Ray machine that may also be affixed to the wall during installation for added stability. All of the Panatome functions such as kVcp, mA, exposure time and all motor functions are computer controlled. There is a touch screen monitor that will display the various technique factors.
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    K Number
    K981466
    Device Name
    XR-910
    Manufacturer
    IMAGING SCIENCES INTL., INC.
    Date Cleared
    1998-07-14

    (82 days)

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

    IMAGING SCIENCES INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XR-910 folds into a compact unit (20" W 54.5" L 21" H). The XR-910 is then easily transported by a van or similar vehicle, to a private residence, nursing home, medical clinic, and other such facilities. With the large 15" pneumatic wheels, and 20" wheelbase and a weight of only 78 lbs., the XR-910 can be easily maneuvered through doorways, hallways, and up and down flights of stairs. This can be accomplished by an average person. Due to the large vertical movement of the tubehead and boom arm, and rotational positions of the tubehead, radiographs may be taken with the patient standing, sitting or supine. Radiographs may be taken of the chest and extremities. The XR-910 is a 60 to 90 kVp, 10 mA unit. Using 800 speed film and screens, exposure times for most radiographs are less than 100 milliseconds.
    Device Description
    The XR-910 Mobile X-Ray unit is a light weight (78 pounds), compact (20" W 54.5" L 21" H), X-Ray System. The system can be easily loaded into a van or similar vehicle for transporting to the site where the unit will be used.
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