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510(k) Data Aggregation

    K Number
    K223550
    Device Name
    DMX
    Manufacturer
    Del Medical, Inc.
    Date Cleared
    2023-04-10

    (136 days)

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

    Del Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DMX is a radiographic system used in hospitals, clinics, and medical practices. The DMX enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult, and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critically ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The DMX is not meant for mammography. The DMX can use a mobile (wired) or portable (wireless) digital detector (not provided with system) for generating diagnostic images by converting x-rays into electronic signals. The DMX is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes
    Device Description
    The DMX System is a permanently-installed diagnostic x-ray system for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. It is intended to produce diagnostic x-ray images of human anatomy. The DMX System enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The resultant images are evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan. It is not intended for fluoroscopy, angiography, or mammography. The DMX System typically includes a tube support, x-ray tube, radiographic table, radiographic wall stand, and collimator. Systems that include the overhead tube crane provide autotracking of the tube crane based on the position of the radiographic table or wall stand.
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    K Number
    K173018
    Device Name
    MDR17 Mobile Direct Radiographic System
    Manufacturer
    Del Medical, Inc.
    Date Cleared
    2017-11-20

    (53 days)

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

    Del Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
    Device Description
    This is a motorized mobile diagnostic x-ray system. The MDR16 Mobile Direct Radiographic System facilitates X-ray examinations, in situations where it is not possible to transport the patient to a ward with fixed equipment. The unit is stable and precise, yet easy to maneuver due to smooth battery-powered motorization. Electric tube unit and wheel locks, 180º column rotation, and a simple user interface provide for add operator convenience and rapid patient positioning. The MDR17 System allows the acquisition of X-ray images on digital panel, CR, or film, by setting techniques based on anatomic area. Technique presets can be customized. Immediate image display after acquisition, and the possibility of immediate transmission to PACS, help minimize workflow time. Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Furthermore, the intended operators of the MDR17 Mobile Direct Radiographic System are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Del Medical, Inc. adheres to recognized and established industry practice, and all equipment is subject to final performance testing. The digital x-ray panel includes automatic exposure detection. Two different size panels are available: 35 x 43 cm or 24 x 30 cm. The software is compatible with either panel via menu setting.
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    K Number
    K152767
    Device Name
    OTC12D AUTO RADIOGRAPHIC SYSTEM
    Manufacturer
    DEL MEDICAL, INC.
    Date Cleared
    2015-12-14

    (81 days)

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

    DEL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTC12D Auto System is a radiographic system used in hospitals, clinics, and medical practices. The OTC12D Auto System enables radiographic exposures of the whole body including; skull, chest, abdomen, and extremities and may be used on pediatric, adult, and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critically ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The OTC12D Auto System is not meant for mammography. The OTC12D Auto System can use a mobile (wired) or portable (wireless) digital detector (not provided with system) for generating diagnostic images by converting x-rays into electronic signals. The OTC12D Auto System is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
    Device Description
    The OTC12D Auto System is a permanently-installed diagnostic x-ray system for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. It is intended to produce diagnostic x-ray images of human anatomy. The OTC12D Auto System enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The resultant images are evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan. It is not intended for fluoroscopy, angiography, or mammography. The OTC12D Auto System typically includes a tube support, x-ray generator, x-ray tube, radiographic table, radiographic wall stand, and collimator. Systems that include the overhead tube crane provide auto-tracking of the tube crane based on the position of the radiographic table or wall stand.
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    K Number
    K140825
    Device Name
    DELWORKS DR SYSTEM
    Manufacturer
    DEL MEDICAL, INC.
    Date Cleared
    2014-07-17

    (107 days)

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

    DEL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DelWorks DR System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. DelWorks DR System allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
    Device Description
    The DelWorks DR System represents the straightforward integration of a number of digital x-ray receptor panels using digital acquisition software. The DelWorks DR System is compatible with all modern HF generators. DelWorks DR System is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) The DelWorks DR System is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. Many of the compatible panels provide Auto-exposure detection. A synchronization module is available where exposure sync is required. This module connects between the digital panel and the x-ray high voltage generator. It provides "ready" synchronization and optical isolation between the two devices. Some of the detectors feature wireless Wi-Fi connection via a wireless access point. The software features Image Stitching (4 views can be combined into one single view) and other image enhancement features. The system software interacts with and controls technique factors of compatible generators via serial interfaces. DICOM output allows for transmission of images to the hospital radiology information system. The system employs Digital Radiography Operator Console (DROC) software, outputs a DICOM image. A USB "dongle" is provided to assure the authenticity of the software.
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