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510(k) Data Aggregation
K Number
K093624Device Name
OPTISCAN MODEL OPTISCAN CEIS
Manufacturer
Date Cleared
2010-03-05
(102 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
OPTISCAN PTY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Confocal Endoscopic Imaging System (CEIS) is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by legally marketed video endoscopes (equipped with a confocal laser imaging module), during endoscopic medical examination procedures. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Device Description
The Optiscan Confocal Endoscopic Imaging System (CEIS) is a software controlled device which is intended for use as a required accessory with a legally marketed and compatible video endoscope system that is equipped with confocal imaging module.
The Confocal Endomicroscopy Imaging System (CEIS) consists of three main units.
- The Control Unit (CEIS-CU) together with its monitor, keyboard, and footswitch, 1. is a computer based unit which performs the instrument control, and image capture and processing functions of the CEIS.
- The Optical Unit (CEIS-OU) a specialised endomicroscope interface unit which 2. performs the laser illumination and fluorescence detection functions of the CEIS.
- 3. The Isolation Transformer.
A video endoscope equipped with a confocal imaging module is connected to the CEIS-OU. Under control by the endoscopist, the CEIS-OU transmits visible laser light into the connected endoscope. The endoscope transmits this light to and then subsequently receives return light signals from the subject tissue. The returned light is detected by the CEIS-OU and converted into an electrical signal. The detected signal is sent to the System Computer (CEIS-CU) which processes the confocal image information for display on the system monitor, and allows still images of the tissue to be captured and stored.
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