Search Results
Found 1 results
510(k) Data Aggregation
K Number
K210052Device Name
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
Manufacturer
Date Cleared
2022-04-01
(448 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Saneso Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Saneso Colonoscope 360-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A, Saneso Processor-A and other ancillary equipment.
The Saneso Gastroscope 360-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consistroscope 360-A/Saneso Single Camera Gastroscope-A, Saneso Processor-A and other ancillary equipment.
The Saneso Single Camera Colonoscope-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and ileocecal valve). The system also provides access for therventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A/Saneso Single Camera Colonoscope-A, Saneso Processor-A and other ancillary equipment.
The Saneso Single Camera Gastroscope-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Gastroscope 360-A/Saneso Single Camera Gastroscope-A. Saneso Processor-A and other ancillary equipment.
Device Description
The Saneso Colonoscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the lower gastrointestinal tract (including the anus, rectum, sigmoid colon, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, colonoscope, video system, light source and other ancillary equipment. The Saneso Colonoscope 360-A is a full circular view video colonoscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images, and forward only view modes. The selection is made through the video interface.
The Saneso Colonoscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Colonoscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the colonoscope, pneumatic control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse, and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with Select Band Imaging or Dual Band Imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The system can be controlled using a mouse and keyboard.
The Saneso Gastroscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, gastroscope, video system, light source and other ancillary equipment. The Saneso Gastroscope 360-A is a full circular view video gastroscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images and forward only view modes. The selection is made through the video interface.
The Saneso Gastroscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Gastroscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the gastroscope, pneumatic control, and control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with select either single band imaging or dual band imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The data is transferred using Wi-Fi or Ethernet. The system can be controlled using a mouse and keyboard.
The Saneso Single Camera Colonoscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the lower gastrointestinal tract including the rectum, colon and ileocecal valve. The system employs Select Band Imaging mode. The Saneso Single Camera Colonoscope-A features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera. LED light assembly, instrument channel outlet, nozzle, tissue wash outlet.
The Saneso Single Camera Colonoscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section.
The Saneso Single Camera Colonoscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing software and serves as a control platform for the Saneso Single Camera Colonoscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
The Saneso Single Camera Gastroscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the upper Gastrointestinal (G.I) tract including the esophagus, stomach and duodenum. The system employs Select Band Imaging mode. The Saneso Single Camera Gastroscope-A consists of the Saneso Single Camera Gastroscope-A which is used in conjunction with the Saneso Processor-A and other ancillary equipment. The gastroscope features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera, LED light assembly, instrument channel outlet, nozzle, tissue wash outlet.
The Saneso Single Camera Gastroscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section.
The Saneso Single Camera Gastroscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing Software and serves as a control platform for the Saneso Single Camera Gastroscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
Ask a Question
Ask a specific question about this device
Page 1 of 1