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510(k) Data Aggregation

    K Number
    K101517
    Device Name
    SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
    Manufacturer
    SEDECAL S.A.
    Date Cleared
    2011-08-05

    (429 days)

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

    SEDECAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skill, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    Sedecal Digital Mobiles (various models) are mobile x-ray units that covers, with a range of models, all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These cordless units combine stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging. Two different brands of digital image acquisition panels are offered: Trixell and Varian. Integrated software for Dicom compatibility is also included.
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    K Number
    K103522
    Device Name
    SEDECAL
    Manufacturer
    SEDECAL S.A.
    Date Cleared
    2011-01-26

    (56 days)

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

    SEDECAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Portable Diagnostic Radiographic System is 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, chest, abdomen, 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
    The Sedecal SPL-HF-4.0 portable x-ray generator consists of: X-ray Unit with: Control Panel with controls and displays for radiographic operations; Power Module containing control and power components; HV Tank that comprises the High Voltage Transformer, the Filament Transformer and the X-ray Tube; and a Collimator with controls to limit the X-ray beam; a Handswitch and a Mobile Column with an Articulated Arm and a Cassette Basket.
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    K Number
    K090322
    Device Name
    EASY MOVING PLUS, SM-XXHF-YY
    Manufacturer
    SEDECAL S.A.
    Date Cleared
    2009-03-17

    (36 days)

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

    SEDECAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These Digital Radiographic Systems are 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, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    Easy Moving Plus is a mobile x-ray unit that covers, with a wide range of models, all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. The cordless Easy Moving "B" (battery powered version) combines stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging.
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    K Number
    K090279
    Device Name
    SEDECAL, MILLENNIUM PLUS
    Manufacturer
    SEDECAL S.A.
    Date Cleared
    2009-03-11

    (35 days)

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

    SEDECAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skall, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    These digital diagnostic x-ray systems consist of a tubehead and collimator assembly mounted on a U-Arm, along with a generator, generator control, and an xray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.
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    K Number
    K090238
    Device Name
    SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
    Manufacturer
    SEDECAL S.A.
    Date Cleared
    2009-02-27

    (25 days)

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

    SEDECAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These Digital Radiographic Systems are 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, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    These digital diagnostic x-ray systems consist of a tubehead/collimator assembly mounted on a U-Arm, along with a generator, generator control, and an x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV, with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.
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    K Number
    K063283
    Device Name
    DEFINIUM 5000 X-RAY SYSTEM
    Manufacturer
    SEDECAL S.A.
    Date Cleared
    2006-11-17

    (18 days)

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

    SEDECAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Definium™ 5000 X-Ray Systems are 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, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    The Definium 5000 Digital Radiographic Imaging System provides state of the art image quality, image manipulation, operator control, dose reporting and system maintenance. These features make this system easy to use and reliable while providing high quality radiographic images in a digital environment. The Definium 5000 System is designed to handle radiographic applications using the digital table. The system configuration includes an elevating or non-clevating table, a floor column stand with rotating U-arm, and GE's patented Digital Detector that captures radiographic images in digital form, as well as an X-ray generator/power unit. An Acquisition and Review Workstation for image post-processing, short-term storage, and quick in-room viewing of images is included as part of the system. Images may be transferred manually or automatically via a DICOM network for printing, longterm storage archive, and detailed review.
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    K Number
    K062335
    Device Name
    SEDECAL X PLUS LP PLUS
    Manufacturer
    SEDECAL S.A.
    Date Cleared
    2006-09-14

    (35 days)

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

    SEDECAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SEDECAL X PLUS LP PLUS Universal Radiographic Systems are 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, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    SEDECAL X PLUS LP PLUS Universal Radiographic Systems are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device employs new controls, including a touch screen and an infrared remote.
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    K Number
    K042876
    Device Name
    URS LP DIGITAL, MILLENNIUM, RADPRO
    Manufacturer
    SEDECAL S.A.
    Date Cleared
    2004-11-18

    (31 days)

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

    SEDECAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sedecal URS LP/Millennium/RadPro Xray Units with Detector are 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, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    URS LP/Millennium/RadPro X-ray Units with Detector are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G. The new units offer additional mounting options for the tube head and other components.
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    K Number
    K043002
    Device Name
    SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
    Manufacturer
    SEDECAL S.A.
    Date Cleared
    2004-11-18

    (17 days)

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

    SEDECAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sedecal Mobile Radiographic Systems with Digital Detector are 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, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    Sedecal Mobile X-ray Units with Digital Detector arc mobile units which operate from 120 or 220 V 50-60~ AC or batteries. The units utilize high frequency inverters. The usual safety precautions regarding the use of xrays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G.
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    K Number
    K020436
    Device Name
    PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0
    Manufacturer
    SEDECAL S.A.
    Date Cleared
    2002-02-22

    (14 days)

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

    SEDECAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Models SP-HF-2.8 and SP-HF-4.0 are 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, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    Models SP-HF-2.8 and SP-HF-4.0 are a portable units which operate from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be either mounted to a tripod or support arm or can be hand held.
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