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510(k) Data Aggregation
K Number
K102529Device Name
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
Manufacturer
STEPHANIX RADIOLOGICAL SYSTEMS
Date Cleared
2010-10-07
(35 days)
Product Code
OWB, IZI, JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
STEPHANIX RADIOLOGICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D'RF Digital Dynamic Remote System Is indicated for use in generating fluoroscopic Images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Device Description
D'RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Canon Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray Images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital Images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table.
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