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510(k) Data Aggregation
K Number
K032761Device Name
KMC-950 C-ARM MOBILE SYSTEM
Manufacturer
UNITED RADIOLOGY SYSTEMS, INC.
Date Cleared
2004-05-14
(252 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
UNITED RADIOLOGY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KMC-950 is intended to provided 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, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures. The system may be used for other RF imaging application at physician's discretion.
Device Description
The KMC-950 is a C-arm X-ray mobile systems consisting of a C-arm stand base and monitor trolley. The C-arm mobile stand holds the high-frequency X-Ray generator, X-ray tube assembly, X-ray controls, image intensifier and CCD camera. Monitor trolley supports the image display TV monitors, image processing and recording devices. KMC-950 are providing a dynamic motion images on the TV monitor in such principles of lower dosage, better image quality and digital manipulation, workflow enhancement, operator and patient comfort and versatility. A general radiographic stationary images are able to produce on x-ray film. Therefore a cassette holder is provided with the mobile system.
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K Number
K032628Device Name
PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF
Manufacturer
UNITED RADIOLOGY SYSTEMS, INC.
Date Cleared
2004-02-02
(160 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
UNITED RADIOLOGY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PXP-HF family of portable X-Ray systems are designed for a general radiographic application in a field or medical clinics use. There are only difference in radiation output and x-ray tube between the portable X-Ray systems.
PXP-20HF and PXP-40HF portables are used with mobile stand systems for Nursing home-care or Private home-care application. When the patients are sick at home, it is very expensive to bring the patients to a hospital by ambulance transportation service for X-ray examination. Therefore hospital sends this portable equipment to the patient's houses and take a X-ray picture on site. This portable and mobile systems has been used on a battle field because of easy mobility,
PXP-15HF portable X-ray systems has been used for Foot & Hand- care clinics or sport medicine group in sport complex or sport stadium for X-ray examination of athletics who are injured during a game.
Device Description
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