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510(k) Data Aggregation

    K Number
    K191623
    Device Name
    ScanX Touch/ScanX Duo Touch
    Manufacturer
    Air Techniques, Inc.
    Date Cleared
    2019-08-21

    (64 days)

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

    Air Techniques, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ScanX Touch/ScanX Duo Touch is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
    Device Description
    The ScanX Touch is a device that scans photostimulable phosphor storage plates that have been exposed in place of X-ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. Two models are available: The Scanx® Touch processes one imaging plate while ScanX® Duo Touch processes two at a time. The ScanX Touch also includes an RFID Phosphor Plate identification system which requires that the Phosphor Plate has an RFID tag attached to the non-imaging side of the Plate. ScanX allows multi room dental clinics to produce digital radiographs within seconds using a flexible PSP (Phosphor Storage Plates). The workflow is supported by a touch screen, for job handling (ScanManager, Patient information), preview and standalone work. ScanX produces the digital diagnostic quality intraoral image by scanning PSPs, which have been exposed to X-rays. ScanX can also work independently. If the IT network goes down, the user can still scan and save X-ray images. The images are temporarily placed in the internal memory and are later transferred to the office database. This makes the device ideally suited to provide a mobile solution when it is necessary to visit the patient outside the office. Additionally, ScanX allows computer storage, processing, retrieval and display of the processed images utilizing a user supplied software (e.g. DBSWIN) and computer. An additional feature of ScanX consists of an in-line plate eraser function that removes the latent image from the plate immediately after scanning. This design provides an efficient one-operation scanning and erasing process leaving the user with a PSP ready for the next X-ray procedure
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    K Number
    K101289
    Device Name
    SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2010-08-03

    (88 days)

    Product Code
    MQB, D50, MOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIR TECHNIQUES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ScanX D5000 series scanners, with and without battery option are devices that read photostimulable phosphor plates that have been exposed in place of x-ray film and allow those images to be displayed on a personal computer display and stored for later recovery in a computer's memory. It will be used by physicians, dentists, veterinarians, and authorized medical auxiliary personnel for this purpose. These scanners are not intended to be used for mammographic images.
    Device Description
    The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
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    K Number
    K090169
    Device Name
    SPECTRA FLUORESCENCE CARIES DETECTION DEVICE
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2009-08-18

    (207 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIR TECHNIQUES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spectra Fluorescence Caries Detection Aid System is indicated as an aid in the detection and diagnosis of dental caries.
    Device Description
    The Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
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    K Number
    K052271
    Device Name
    RINSENDO
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2006-05-26

    (280 days)

    Product Code
    NYL
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIR TECHNIQUES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RinsEndo is used for root canal irrigation/ disinfection.
    Device Description
    Not Found
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    K Number
    K050693
    Device Name
    ACCENT
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2005-05-26

    (70 days)

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

    AIR TECHNIQUES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accent Sensor is a digital x-ray sensor system for human and non human use in dental, medical and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues. Accent replaces standard X-ray film and/or phosphor plate technology.
    Device Description
    The X-ray tube (not part of this product) is pointed at the sensor and activated. The X-ray energy is detected by the sensor and transmitted as data to the computer to which it is connected. The software (not part of this product) interprets the image as a gray scale image and displays it on the computer monitor for diagnosis.
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    K Number
    K042397
    Device Name
    SCANX 14
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2004-10-05

    (33 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIR TECHNIQUES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by physicians and authorized medical auxiliary personnel for this purpose.
    Device Description
    The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory.
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    K Number
    K042266
    Device Name
    ACCLAIM
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2004-08-31

    (8 days)

    Product Code
    NRD
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIR TECHNIQUES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acclaim system is primarily a tool to provide visual information to dental patients so that they can better understand the necessity and quality of the health care they receive.
    Device Description
    Not Found
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    K Number
    K031198
    Device Name
    SCANX 10
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2003-06-20

    (65 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIR TECHNIQUES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K024285
    Device Name
    A/T X-RAY 70
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2003-04-16

    (114 days)

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

    AIR TECHNIQUES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors) for the purpose of radiographic examination and diagnosis of diseases of the teeth.
    Device Description
    The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors).
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    K Number
    K013893
    Device Name
    SCANX
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2002-02-01

    (70 days)

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

    AIR TECHNIQUES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
    Device Description
    The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory.
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