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510(k) Data Aggregation
K Number
K101734Device Name
VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
Manufacturer
VISIONSCOPE TECHNOLOGIES, LLC
Date Cleared
2010-09-08
(79 days)
Product Code
HRX, GCJ
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
VISIONSCOPE TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VisionScope High Definition Endoscopy Camera System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening. Examples of generic surgical use include imaging of articular cavities, body cavities, hollow organs and canals.
Additionally, when used in conjunction with an appropriately indicated and FDA 510(k)cleared endoscope and light source, the VisionScope High Definition Endoscopy Camera Control Unit and Camera Handpiece are indicated for use in arthroscopic and endoscopic surgical procedures to provide illumination, visualization and capture of still and motion pictures of articular cavities, body cavities, hollow organs and canals.
Device Description
The VisionScope High Definition Endoscopy Camera System is made up of the following components:
- · Integrated Camera Control Unit containing the camera control electronics, light source and image capture electronics
- Camera Handpiece .
- . VisionScope line of four Endoscopes of identical design except for the lengths
- . VisionScope Disposable Sterile Procedure Kits in four matched lengths as the endoscopes
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