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510(k) Data Aggregation
K Number
K970824Device Name
MDX 2000, DIGITAL ANALYZER
Manufacturer
Date Cleared
1997-05-30
(85 days)
Product Code
Regulation Number
864.5260Why did this record match?
Applicant Name (Manufacturer) :
**SHOTWELL **& CARR, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Automated scanning microscopy work station for histological identification of the enzyme leucocyte alkaline phosphatase in neutrophilic granulocytes to differentiate: Granulocytic leukemia; a malignant disease characterized by excessive overgrowth of granulocytes in bone marrow, and Reactions that resemble true leukemia, such as those occurring in severe infections.
Device Description
The MD, 2000 Digital Analyzer is an automated intelligent microscope cell locating device that detects, by color and pattern recognition techniques, cells stained with alkaline phosphatase reagent system FAST VIOLET B SALT. The system consists of software resident in computer memory and includes keyboard, color monitors, microscope, printer, and an automatic slide handling and scanning mechanism controlled and operated by a health care professional.
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K Number
K961011Device Name
DTX-200 BONE DENSITOMETER
Manufacturer
Date Cleared
1996-07-05
(114 days)
Product Code
Regulation Number
892.1170Why did this record match?
Applicant Name (Manufacturer) :
**SHOTWELL **& CARR, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To estimate bone mineral content (BMC, grams) and bone mineral density (BMD, grams/cm').
Device Description
The DTX-200 candidate device is a dual energy system, where the measured object, in this case the forearm, by the software, i s 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 55 kV , with a current of 300 yAmps. 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 4 minutes. The effective patient dose is estimated to be 0.1 micro Sievert per scan.
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