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510(k) Data Aggregation
K Number
K100703Device Name
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
Manufacturer
Date Cleared
2010-12-21
(284 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
COMED CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ATLAS is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Atlas is not intended for mammography.
Device Description
The Atlas is provided high resolution radiographic images in a digital format without use of film, chemistry, cassettes or expensive imaging plates. With 98% of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector.
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