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510(k) Data Aggregation
K Number
K093790Device Name
SIMONDR DRP
Manufacturer
Date Cleared
2010-04-05
(116 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
SIMONDR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Models SimonDR DRP Digital X-Ray Imager is a digital x-ray Imager intended for physicians or technologists operating under the guidance of the physician, to use for diagnostic x-ray imaging in podiatric practices instead of using a film based system.
Device Description
The SimonDR Inc. model DRP is used to directly capture and convert conventional projection X-Ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for podiatric radiographic examinations.
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