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510(k) Data Aggregation
K Number
K133496Device Name
X TWIN SYSTEM
Manufacturer
Date Cleared
2014-12-03
(384 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ROESYS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position.
The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres.
Device Description
The X Twin is a digital multifunctional x-ray system, in which an X Twin stand holds the xray image receptor, the collimator and the x-ray tube including the x-ray tube housing assembly. The generator, x-ray tube, beam limiting device, image receptor, including the workstation for image processing plus imaging software and the optional mobile x-ray table are known components. The geometry of the X Twin contains two guide frames, two support arms, an x-ray tube column and an image receptor column. The movements of the columns and the arms as well as the SID adjustment are motorized. The x-ray tube support arm as well as the image receptor support arm is provided with an integrated control unit, located at the front of the support arms. These units allow an adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. Additionally an integrated touch display for indication of current values and additional control options is implemented in the tube support arm. The device receives its power from the x-ray generator.
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