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510(k) Data Aggregation
K Number
K221642Device Name
SIRIUS Endoscope System
Manufacturer
Precision Robotics (Hong Kong) Limited
Date Cleared
2022-12-12
(189 days)
Product Code
HET, FGB, GCJ
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
Precision Robotics (Hong Kong) Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity.
Device Description
The SIRIUS Endoscope System as a robotic endoscope consists of Video Processor, Laparoscope Handle, Laparoscope Head and Joystick. The SIRIUS Endoscope System is developed for minimal invasive surgery application. The SIRIUS Endoscope System is a fully integrated compact 3D laparoscopic camera system with a flexible tip that can change its viewing direction. The Laparoscope Head is made of biocompatible materials. The articulated tip has three degrees of freedom enabling C and S shaped bending. The insertion is 10 mm diameter and 340 mm working length. Stereo camera with 1080 high-definition resolution. It has 120 degrees field of view, 10-100mm depth of view and bright light with 300 lumen.
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