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510(k) Data Aggregation
K Number
K082261Device Name
DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
Manufacturer
Date Cleared
2008-11-06
(90 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
DXRAD SOLUTIONS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic ratiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the pationi sitting, standing, or lying in the prone or supine position.
Device Description
This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a U-Arm suspension along with a generator, generator control, and a mobile patient table. Power ratings for the available generators are in the rage of 32 kw to 80 kW. 64 kw is the standard size. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10s. The system is provided with a digital imaging detector, either the QXR16 or the QXR9 CCD Image Detector and Acquisition Workstation. This device represents the interconnection of two already cleared devices: The X-ray system and the digital detector system.
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