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510(k) Data Aggregation

    K Number
    K021331
    Device Name
    DEXACARE G4
    Date Cleared
    2002-05-21

    (25 days)

    Product Code
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOMETER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To estimate bone mineral content (BMC, grams) and bone mineral density (BMD, grams/cm²).
    Device Description
    The DexaCare® G4 is a cost effective, table top bone densitometer. The DexaCare® G4 is a modification of the predicate Osteometer MediTech DTX-200 device listed in 510(k) K964562. The DexaCare® G4 candidate device is a dual energy system, where the measured object, in this case the forearm, by the software, is divided into two compartments, bone and soft-tissue. Having two energies, and two compartments (unknowns) it is possible to establish and solve two formulae with two unknowns. The X-ray generator is driven at 55kV, with a current of 300pAmps. The beam is filtered with Tin (Sn), using the K-Edge of this material to enhance the separation of the low and the high energy. The average energy peaks are approximately 29 keV, and 46 keV respectively. A highly stable X-ray output, together with a source collimation of 1 mm and a pixel resolution of 0.4mm X 0.4mm, yields images of very high quality. The detector is a sandwich construction, using solid state photodiodes consisting of two diodes with scintillation material. The two energies are separated by the sandwich construction. The X-ray beam meets the first scintillator, where predominantly the low energy is detected, and then it meets the second scintillator, where the rest of the energy is detected. The typical time to estimate bone mineral content and bone mineral density is approximately four minutes. The effective patient dose is estimated to be 0.1 micro Sievert per scan.
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