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EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XP190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-P190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

The EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-XP190, OLYMPUS BF-P190, and BF-XT190) and BRONCHOVIDEOSCOPE BF-H1100 and BF-1TH1100 are used for endoscopic diagnosis and treatment within the respiratory organs. These endoscopes consist of three parts: the control section, the insertion section, and the connector section.

The Grumpy Innovation PORTARE System is intended to endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor. The endoscope is intended for use in a hospital or clinical environment. It is intended for use in adults.

The Grumpy Innovation PORTARE System is a flexible endoscope with steerable navigation and a built-in image and video processing system that wirelessly transmits images and video to a tablet application. The PORTARE System is comprised of a: • Sterile, single-use disposable endoscope handle, steering mechanism, and steerable insertion tube with chip-on-tip camera and LED light source. • Reusable module comprising the primary circuit board with wireless unit and rechargeable battery. • Tablet viewer that runs a software application. The reusable module attaches to the single-use disposable endoscope handle to create a functional endoscope.

The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with endoscopes, video endoscopes, camera heads, monitors and other ancillary equipment for endoscopic surgery, is intended to receive and process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor. Also, the VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with rhinolaryngeal stroboscopes, is intended to observe the intralaryngeal phenomenon of phonation (speech) for endoscopic observation to examine the correct functioning of the vocal apparatus (glottis) and to examine voice disorders.

The OLYMPUS OTV-S500 is a "universal platform" which offers compatibility with various endoscopes for different medical specialties and enables efficient operation to meet the clinical needs of the ENT field; the device has been cleared by FDA for use with OLYMPUS urology/gynecology endoscopes (including CYF-VH, CYF-VHR, URF-V2, URF-V2R, URF-V3. URF-V3R. WA2T400A. WA2T412A. WA2T430A. WA2T43WA. WA2T470A. WA2UR11A, WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, WA2UR32A, CYF-5, CYF-5R, URF-P6, URF-P6R, URF-P7, URF-P7R and HYF-XP) under K241371. The OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units (cooling fan, unit power supply, and control panel), harnesses between circuit boards, and optical components (lens and optical filter). A microprocessor is built into the OLYMPUS OTV-S500 which controls processing of observation images, user interface (front panel switch, indicator LEDs, warning buzzer etc.) and menu. These functions are implemented in the embedded software. Scopes including flexible videoscopes or fiberscopes and rigid videoscopes with camera heads and light source are directly connected to the Subject system. When connected, the endoscope (fiberscopes and rigid videoscope without camera head) acquires and displays images directly to the user or output onto a monitor when using a flexible endoscope or scope and camera head. The Subject devices submitted for clearance include one (1) major component: the Video System Center (OLYMPUS OTV-S500) with Foor Holder (MAJ-2552), and five (5) optional accessories: an HDMI cable (MAJ-2551); the OTV-S500 Upgrade Pack Strobe (MAJ-2547), which activates the stroboscopy function of the OTV-S500; an Air Microphone (MAJ-2548); a Throat Microphone (MAJ-2549); and the Microphone Extension Cable (MAJ-2550). The OLYMPUS OTV-S500 is compatible with the following OLYMPUS ENT endoscopes: ENF-VH, ENF-VH2, ENF-V3, ENF-V4, ENF-VT3, ENF-XP, ENF-GP2, WA4KS400, WA4KS430, WA4KS431, WA4KS445, WA4KS446, WA4KS471, WA4KS471, WA96100A and WA96105A.

MonoStereo is intended to be used together with 2D monoscopic endoscope systems to provide simulated 3D visualization for observation during ENT diagnostic and therapeutic procedures.

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The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via an Image Processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.

The Rhinolaryngoscope System consists of Single-Use Rhinolaryngoscope (six models shown in below) to be introduced within the nasal lumens and upper airway anatomy and Image Processor (model: VLM-02) for clinical image processing. The Image Processor provides power and processes the images for medical electronic endoscope. The Single-Use Rhinolaryngoscope is a sterile single used flexible Rhinolaryngoscope. The Image Processor is a reusable monitor.

ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.

The ATMOS Scope is a flexible nasopharyngo laryngoscope for endoscopic diagnosis within the nasal lumens and airway anatomy. The device is an electrical device and consists of a handle for the user and a flexible, steerable part that is inserted into the patient. The deflection lever can be easily operated with the thumb and enables precise control of the endoscope tip at an angle of 2 x 135°. This makes it easy to examine even hard-to-reach regions in the nose, or throat. The device contains two integrated LED light sources that provide bright and homogeneous illumination in the complete field of view. With the help of a 1280 x 800-pixel image sensor at the flexible part and the electronics built into the handle, a digital image is generated. For taking and saving photos and videos, the ATMOS Scope has two separate function keys located directly on the handle. This can be displayed as the endoscopic image on a connected PC with video software. The endoscopic image is used for visual diagnostics by the user. The ATMOS Scope is delivered in a non-sterile condition.

The Patcom Distal Chip Endoscope is indicated when endoscopic visualization in the regions of mouth, nasal cavity, and upper airway is required.

The PatCom Distal Chip Endoscope is a portable video endoscope for visualization in the reqions of the mouth, nasal cavity, and upper airway. It is made up of the grip section and insertion tube. It requires connection via USB to a laptop computer, and gains power from the USB ports which supplies 5V of electricity with a maximum current of 0.5A. This is sufficient to power the endoscope. The endoscope does not need an external CCU for image processing, as the processing is done directly on the device on a small chip. It converts the light and color information received by the image sensor into binary numbers (patterns of zeros and ones). The USB Video Class (UVC) driver is a Microsoft-provided AVStream minidriver that provides driver support for USB Video Class devices. When a device uses UVC, it does not need to support their own driver, but instead works automatically with the system-supplied driver. It is compatible to all Windows and Mac computers, with a simple plug and play feature. The visualization from the distal chip is projected onto the computer monitor, at a resolution of 720px1280p high definition. The insertion tube portion of the device is used for visualization within the natural orifices of the mouth and the nasal cavities and in the upper airway anatomy. The light emitted by the LED light source at the distal end of the tip is illuminated into the body cavity of the subject, and the image is displayed onto a screen. The grip section of the device contains a control knob for moving the distal end of the insertion tube bend up or down, up to 130 degrees in either direction. The proximal end of the grip section contains the USB connector, for plug and play with a computer, for power and to provide visualization of the camera chip found at the distal end of the insertion tube.

The Single-use Flexible Rhinolaryngoscope is designed to be used with the Digital Video Monitor, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible. The Digital Video Monitor is specially designed to be used with endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation. The Vathin® Video Rhinolaryngoscope System is for use in a hospital environment.

The Vathin® Video Rhinolaryngoscope System consists of Single-use flexible Rhinolaryngoscope (eight models shown in below) and Digital Video Monitor (model: DVM-A1, DVM-A2, DVM-B1, DVM-B2) for clinical image processing and display. The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible. The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation. There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function. Single-use flexible Rhinolaryngoscope is a sterile single Rhinolaryngoscope. Digital Video Monitor is a reusable monitor. The light emitted by the LED cold light source of the Single-use flexible Rhinolaryngoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Digital Video Monitor via the encoding circuit. The Digital Video Monitor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal. Single-use flexible Rhinolaryngoscope has the following physical and performance characteristics: - Maneuverable tip controlled by the user . - Flexible insertion cord . - Camera and LED light source at the distal tip . - . Sterilized by Ethylene Oxide - For single use The differences between the Single-use flexible Rhinolaryngoscope models are as follow: - . Have or haven't working channel - . Working channel inner diameter - . Insertion tube outer diameter - . The length of insertion tube

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.

The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.

The Single-use Flexible Rhinolaryngoscope can be connected to the compatible Vathin Display Units and other accessories for examination and treatment of nasal cavity and upper respiratory tract. There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.