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510(k) Data Aggregation
K Number
K052541Device Name
MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM
Manufacturer
Date Cleared
2005-11-03
(49 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
AVANT MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Device Description
HF50-R High Frequency Special Radiography System can be applied in hospitals of different levels to meet the requirements of radiographic diagnosis. The system is complete, consisting of a 50kw generator, X-Ray tube assembly, collimator, tube mounting hardware, and an x-ray table. This product is applicable to clinical diagnostic radiography in all hospitals large or small. It has functions such as ionization chamber automatic exposure control (AEC), automatic radiography (APR), general radiography etc. It is applicable to the radiography of various parts of human body. It is a dedicated radiographic device for gastro-intestinal tract and the like. The technical characteristics parallels to that in the world in the late '90s of last century. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380V, 50/60Hz; single phase: 220V, 50/60 Hz; fluctuation range for voltage: 10%; capacity: 55kVA. Environment requirements: temperature: 15-35C; relative humidity: 45-75%. Atmospheric pressure: 80.0kPa-106.0kPa.
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