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510(k) Data Aggregation

    K Number
    K964562
    Device Name
    DTX-200 BONE DENSITOMETER
    Manufacturer
    OSTEOMETER MEDITECH A/S
    Date Cleared
    1997-08-22

    (282 days)

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

    OSTEOMETER MEDITECH A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Estimate bone mineral content (BMC in grams) and bone mineral density (BMD in grams/cm²) in the distal section of the forearm.
    Device Description
    The DTX-200 candidate device is a dual energy system, where the measured object, in this case the forearm, is submerged into a soft tissue equivalent water bath. The X-Ray generator is driven at 55 Kv, with a current of 0.3 mAmps. The detector uses a scintillating crystal and a solid state dual energy sandwich detector. A highly stable X-Ray output, together with a source collimation of 1 mm diameter, and excellent pixel resolution, yields images of very high quality. The typical time to estimate bone mineral content and bone mineral density is approximately 3.0 to 4.5 minutes. The effective patient dose is estimated to be 0.1 micro Sievert per scan. Both the DTX-200 candidate and the DTX-200 predicate bone densitometer devices consist of a computer, keyboard, monitor, printer, and scanner system using an X-ray transmission source. The DTX-200 candidate device and the DTX-200 predicate device are identical and use dual X-ray photon absorptiometry (DXA) to estimate bone mineral content (BMC) and bone mineral density (BMD). Both the candidate and predicate DTX-200 devices are identical and use water as soft tissue equivalent material. Both the DTX-200 candidate device and the DTX-200 predicate device use a line-by-line calibration system, ensuring good precision.
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    K Number
    K963789
    Device Name
    DTX-100 BONE DENSITOMETER
    Manufacturer
    OSTEOMETER MEDITECH A/S
    Date Cleared
    1997-07-14

    (297 days)

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

    OSTEOMETER MEDITECH A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Estimate bone mineral content (BMC in grams) and bone mineral density (BMD in grams/cm²) in the distal section of the forearm.
    Device Description
    The DTX-100 candidate device is a single energy system, where the measured object, in this case the forearm, is submerged into a soft tissue equivalent water bath. The X-Ray generator is driven at 40 kV, with a current of 0.2 mAmps. The detector uses scintillating crystal and a photomultiplier tube. A highly stable X-Ray output, together with a source collimation of 1 mm, and excellent pixel resolution, yields images of very high quality. The typical time to estimate bone mineral content and bone mineral density is approximately 3.0 to 4.5 minutes. The effective patient dose is estimated to be 0.01 micro Sievert per scan.
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