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510(k) Data Aggregation
K Number
K101810Device Name
3DHJD CAMERA SYSTEM MODEL
Manufacturer
VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS
Date Cleared
2010-08-30
(62 days)
Product Code
GCJ, FET
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use during diagnostic and/or surgical procedures when endoscopic video assistance is required.
For use in all types of video assisted minimally invasive procedures including: general surgery, gynecologic, thoracic, urologic, bariatric, spinal, ENT and as an aid in visualization of cardiac structures.
Device Description
The Viking 3DHD Video Camera System consists of camera heads, 3D endoscopes, and a camera controller. The system can be used with commercially available light sources, light cables, 2D endoscopes, couplers, and 2D and 3D video monitors or head mounted displays.
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K Number
K081585Device Name
ENDOSCOPY VIDEO CAMERA SYSTEM
Manufacturer
VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS
Date Cleared
2008-06-20
(15 days)
Product Code
FET
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endoscopy Video Camera System is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required.
Device Description
The Endoscopy Video Camera System consists of a camera head and a camera controller. The system can be used with commercially available endoscopes and light sources and video monitors or head mounted displays.
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