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The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III Surgical Imaging System is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation and supports the function of high definition (HD) videoscopes and is Camera Head (CH) compatible. The following devices of the VISERA ELITE III Surgical Imaging System are the subject of this premarket notification submission: - **VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model: OLYMPUS OTV-S700)** - A video system center that processes electronic signals transmitted from a video endoscope or a camera head and outputs the image signal to a monitor. - **VISERA ELITE III 3D Upgrade Pack (Model: MAJ-2511)** - A function activation portable memory key accessory that unlocks the 3D software function when connected with OTV-S700 to enable the observation of 3D mode. - **VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model: OLYMPUS CLL-S700)** - A LED light source provides examination light to a video endoscope and a camera head. - **4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (Model: OLYMPUS CH-S700-XZ-EA)** - A 4K Inline camera head is intended to be used with Olympus endoscopes, the video system center, and other ancillary equipment for the visualization of internal organs (endoscopic diagnosis), treatment and observation.

VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R : These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney. EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 : This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 : This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system with the compatible cystscopes is intended for endoscopic diagnosis, treatment and video observation of the bladder, urethra, ureter, and kidney. The primary components of the subject system are: VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R (CYF-V2, CYF-VA2, CYF-V2R) EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180

The Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US is intended for use in automated color shade-matching to assist in dental restoration. The targeted teeth for color analysis are the left and right central incisors, lateral incisors and canines.

The Crystaleye Device is an automated color shade-matching device, based upon a database of reference tooth shades. The Crystaleye Device is comprised of the following components: Spectrophotometer, AC Adapter, Cradle, Contact Cap (5 pcs.), AC Cable, USB Cable, Master CDs, and Instructions. A personal computer is also required to run the Master CDs. The reference color tooth shades of multiple dental restoration manufacturers are loaded into the computer. The spectrophotometer captures an image of the target tooth, and the software matches a patient's color tooth shade with the closest available shade in the computerized reference database.

The EndoArm system consists of the EndoArm, a stabilizing fixation(adapter), Neuroendoscope (A1**A series). A number of components and accessories are also necessary for this system. ● EndoArm This product has been designed for manipulation and positioning of the Neuroendoscope during neurosurgery and spinesurgery. ● Neuroendoscopes (A81000A, A81001A, A81002A, A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A) The Neuroendoscopes are intended for use in observation and diagnosis of the brain ventricles and brain parenchyma, such as observation and diagnosis of cerebral aneurysms, hypophysis tumors, hematomas, brain tumors, cerebral vascular systems, cranial nerve and vascular compression syndromes as well as observation and diagnosis of lumber and cervical spine, such as herniated disc material, nerve roots and nucleus material.

Subject device is a neurological endoscopy system, which consists of EndoArm, a stabilizing fixation component (adapter) and a family of rigid neurological endoscope. A number of component and accessories are also necessary for this system. (1) EndoArm: Mechanical: The Endoarm counter balance arm is designed to deliver smooth endoscope movement and steady fixation by use of compressed nitrogen gas to control the arm movement. The shape of the stand differs from the predicate device in that the predicate device is a bedside fixed design and subject device is a floor stand type. This allows physicians to move the endoscope near the target site only. Illumination: The illumination is supplied by the Neuroendoscope through the light guide cable connected to the separate high intensity light source, OLYMPUS CLV-S40. This light source utilizes a Xenon 300W bulb. Imaging: Another significant difference from the predicate device is the ability of the EndoArm to manage image data from the Neuroendoscope and allow the user to adjust zoom, focus and manage intego adda resiste the EndoArm from fine adjustment of the endoscope potion to image adjustment by one hand. This feature is accomplished by the connection of the Neuroendoscope through the adapter (A81020A) on the EndoArm. The image from the distal end of Neuroendoscope is transmitted to the monitor via the CCD of OTV-S7V camera head, mounted in the EndoArm. (2) Neuroendoscope ( model: A81000A, A81001A, A81002A,A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A): Ten telescope models are discussed in this premarket notification. The range of specifications covers two different insertion diameters ( ø 2.7mm / ø 4mm), five different working lengths (107mm/ 110mm / 112mm/134mm/ 137mm) and five different fields of view (0/ 30/ 70/ -30/-70 ( rorme). The crank shaped endoscope offers the largest operation space and microscopic dog. The craint on onail. In one doscope models are substantially equivalent to the predicate Neuroendoscope (#k971340). (3) Adapter ( model: A81020A): The subject device is an adapter for connecting the Neuroendoscope A810**A series to the EndoArm stabilizing fixation device.

This instrument has been designed to be used with an OLYMPUS compact i nici intrasound center, video system center, light source, documentation endoscopic uitraoound ochter, wtterrapy accessories and other ancillary equipment equipment, video mornior, Endo trony . for endoscopic real time ultrasonic imaging, ultrasound guided needle aspiration and for ondoscopic rour and and within the airway and trancheobronchial tree and the gastrointestinal tract and surrounding organs.

The subject device has been designed to be used with the OLYMPUS EU-C60 EUS EXERA Compact Endoscopic ultrasound center, OLYMPUS video system center, light source, documentation equipment, display monitor, Endo-therapy accessories such as an aspiration biopsy needle. The subject device is designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airways and trancheobronchial tree and the gastrointestinal tract.

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)"has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interfocking operation of the ancillary equipment.

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 2" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment. Addition of the operating function for ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD and SonoSuro-IU) enables the following: - The operating function for ancillary equipment operates the additional ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD and SonoSurg-IU) by Nurse's control panel and voice control. The voice control function enables the subject device to control the ancillary equipment by voice. You will find the details for voice commands and voice controllable equipment in "Standard set and ancillary equipment" and "Operation by voice control" in G. Device Description and Comparison. The intended use of the EndoALPHA is to enable a central system to control various pieces of ancillary equipment. However, the approved indications for use for each separate ancillary device dictate the type of procedures that may be performed. This information is included in the instruction manual for each anciliary piece of equipment.

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

The subject device, Bronchovideoscope Olympus XBF-D160HM, is basically identical to the predicate device, EVIS EXERA Bronchovideoscope Olympus BF type 160, except that the subject device is equipped with an optical system for high magnification observation in addition to an optical system for normal observation. When compared to the predicate device, this high magnification bronchoscope enables more detailed observation of the target area. For example, a run of the capillary blood vessel in the bronchial mucosa can be observed, which is not observable with the predicate device.