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510(k) Data Aggregation
K Number
K120034Device Name
RADIOGRAPHIC X-RAY SYSTEM
Manufacturer
Date Cleared
2012-04-17
(104 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DF-211H Radiographic X-Ray system is designed to be used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images 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
The DF-211H Radiographic X-Ray system is complete, consisting of a 50kW X-Ray generator, control console, X-Ray tube assembly, collimator, and radiographic table. This product is applicable to clinical diagnostic radiography in all hospitals whether large or small. It has functions such as general radiography, anatomic program radiography (APR), etc. It has option of ionization chamber automatic exposure control (AEC). It is applicable to the radiography of various parts of human body. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380V, 50Hz; single phase: 120V, 60 Hz; fluctuation range for voltage: 10%; the power source capacity: 50kW.
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