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The Bioptigen EnFocus™ device is intended to acquire, process, display and save depth resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The EnFocus™ is indicated for use as an aid in the visualization of physiologic and pathologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient populations from premature and neonatal infants to adult. The system is indicated for use in supine imaging, mounted to a surgical microscope, with cooperative patients or patients under anesthesia.

The EnFocus™ is a non-contact, noninvasive ophthalmic imaging device that includes an OCT engine, a scan head and a system computer with system software. The EnFocus™ uses Spectral Domain Optical Coherence Tomography (SD-OCT) and a near infrared light source to image ocular tissue microstructures. The EnFocus™ is coupled to a surgical microscope for OCT imaging during ophthalmic surgical procedures. The software, InVivoVue™, works with the hardware and the controller to offer intuitive, flexible system control for high-speed volume data acquisition and imaging. The EnFocus™ system includes two OCT-compatible objective lenses for use with the surgical microscope: a 175mm lens and 200mm lens. The system also offers a choice of accessory masks that may be deployed to manage illumination glare artifacts when necessary. Using the EnFocus™, OCT imaging may be acquired during the surgical procedure, without stopping a procedure or repositioning the surgical microscope. The surgical microscope position is stationary relative to the surgical procedure, and the surgical view is unaltered by the scanning of the OCT beam.

The Bioptigen EnFocusTM device is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The EnFocusTM is indicated for use as an aid in the visualization of physiologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient promotions from premature and neonant lintants to adult. The system is indicated for use in supine imaging, mounted to a superiod microscope, with coperative patients or patients under anesthesia.

The EnFocus™ is a non-contact, noninvasive ophthalmic imaging device that includes an OCT Engine, a scan head, a System Computer, an Uninterruptible Power Supply (UPS), a mobile Security Cart and the System Software. The EnFocus™ uses Spectral Domain Optical Coherence Tomography (SD-OCT) and a near infrared light source to image ocular tissue microstructures. The EnFocus is coupled to a surgical micrsoscope for OCT imaging during ophthalmic surgical procedures. The EnFocus has been validated and found to be compatible for use with the Leica M844 Surgical Microscope and the Insight Instruments Super View™ Wide Angle Viewing System™ for retina visualization. The software, InVivoVue™ Version 2.6, works with the hardware and the hardware controller to offer intuitive, flexible system control for high-speed volume data acquisition and imaging. The EnFocus™ system includes two OCT-compatible objective lenses for use with the surgical microscope: a 175mm lens and 200mm lens. The system also offers a choice of accessory masks that may be deployed in the Leica M844 filter port to manage illumination glare artifacts when necessary. Using the EnFocus™, OCT imaging may be acquired during the surgical procedure, without stopping a procedure or repositioning the surgical microscope. The surgical microscope position is stationary relative to the surgical procedure, and the surgical view is unaltered by the scanning of the OCT beam.

Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The Envisu SDOIS is indicated for use as an aid in the diagnosis of physiologic and pathologic conditions of the eye through non-contact optical imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in upright or supine imaging, handheld or mounted, and is suited for imaģing patients under anesthesia.

The Envisu™ SDOIS is a non-contact, non-invasive and mobile ophthalmic imaging device that can be used to view ocular tissue physiology and pathology through the interaction of light with the optical scattering properties of structures of the eye. Like its predicate, the Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is a nearinfrared scanning imaging medical device designed to capture depth-resolved images of ocular tissue microstructure. It is available in "high (HR)" and "very-high (VHR)" resolution based on the SLED light source chosen. Each option includes an optical engine, a scanning head, an interchangeable lens set, a computer and the InVivoVue™ Clinic software for imaging of ocular tissue microstructures. The smaller system footprint and mobile security cart easily accommodate any clinical environment. The optical engine includes a low power broadband LED light source with bandwidths of 40 - 100 nm operating in the wavelength range between 760 - 930 nm and a spectrometer that detects backscattered radiation. The scanning head is flexibly designed to be used mounted or handheld for the mutual convenience and comfort of patient and ciinician. Handheld use of the light-weight (< 3.5 lbs), compact handheld scanner makes it possible to image pediatric patients, supine patients, or any patient that finds it difficult to sit upright or where it is clinically preferable to image without the constraint of a chin rest. Tabletop, chin-rest mediated imaging is enabled though a mounting accessory.

The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.

The Bioptigen Spectral Domain Ophthalmic Imaging System is a noninvasive imaging device which provides microscopic tomographic sectioning of the retina with <= 6 microns axial resolution. The Bioptigen System is capable of 20,000 A-Scans/second due to the nature of spectral domain optical coherence tomography. The Bioptigen Spectral Domain Ophthalmic system is composed of a host computer, engine, and probe. The OCT engine is driven by instrument cards in the computer. The device software will allow a user to create, display, load, and save image files (OCT files).