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510(k) Data Aggregation
K Number
K103425Device Name
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
Manufacturer
GENORAY AMERICA INC.
Date Cleared
2011-03-29
(127 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
GENORAY AMERICA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ZEN-7000 Digital mobile Imaging system is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Device Description
ZEN-7000 mobile fluoroscopy system is an image intensified fluoroscopic system consisting of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and an image intensifier. The Mainframe is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The Workstation is a mobile platform that supports image display monitors and recording devices.
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