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510(k) Data Aggregation
K Number
K160518Device Name
LEONI ORION System
Manufacturer
LEONI CIA CABLE SYSTEM
Date Cleared
2016-07-14
(141 days)
Product Code
JAI
Regulation Number
892.5770Why did this record match?
Applicant Name (Manufacturer) :
LEONI CIA CABLE SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LEONI Orion System in an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
Device Description
The LEONI ORION System is an electro-mechanical robotic arm capable of motion in six degrees of freedom. The purpose of the device is to position a patient during radiotherapy, radiology and other medical applications with a high degree of accuracy and repeatability.
The LEONI ORION System consists of the electro-mechanical unit that is a 6 axes robot which supports a standard radiotherapy table couch or other approved patient support device, and a Control Unit that includes computers and application software. The robot is linked to the Control Unit by cables.
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