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510(k) Data Aggregation
K Number
K022114Device Name
IMPERIUM
Manufacturer
ELMSTECH, INC.
Date Cleared
2002-09-17
(81 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
ELMSTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMPERIUM is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography (DSA), orthopedic, neurologic, abdominal, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at physician's discretion.
Device Description
The IMPERIUM is a mobile c-arm x-ray imaging equipment consisting of a carm stand and a monitor trolley. The c-arm stand holds the high-frequency x-ray generator, x-ray tube assembly, x-ray controls, image intensifier and TV camera. Monitor trolley supports the image display monitors, image processing and recording devices.
The IMPERIUM is designed to provide the user with smooth lincar and rotational movements around patient without need of further reorientations. The C-arm movements are fully motorized for ease of operation.
The IMPERIUM is designed according to such principles as lower dosage, better image quality and manipulation, workflow enhancement, operator and patient comfort and versatility. The IMPERIUM can be operated at Fluoroscopy, Pulsed Fluoroscopy, Digital Radiography, Cassette Radiography, Digital Subtraction Angiography (DSA) and Roadman modes. Image processing and storage capabilities such as last image hold, recursive filtering, real time edge enhancement, real time zooming, image reversal, continuous image rotation, radiation-free collimation and contrast/brightness adjustment are possible under user control.
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