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510(k) Data Aggregation
K Number
K162909Device Name
CSX-30 Flat Panel Detector
Manufacturer
Canon, Inc. Medical Equipment Group
Date Cleared
2017-01-27
(102 days)
Product Code
MQB, JAA
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Canon, Inc. Medical Equipment Group
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The flat panel detector CSX-30 is designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include angiography, endoscopy, urologic, orthopedic, neurologic, vascular, critical-care and emergency room procedures or other imaging applications at the physician's discretion. The device is intended to replace spot-film device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Device Description
The CSX-30 is a digital radiography flat panel detector that can take fluoroscopic and spot radiographic images of any part of the body. It directly converts the X-ray images captured by the sensor into high-resolution digital images. The instrument is a component of an x-ray system and as such cannot be used outside of such a system. This unit converts the X-rays into digital signals. Not intended for mammography applications.
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