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The 4Sight is a multi-purpose diagnostic ophthalmic ultrasound system intended to make axial length, anterior chamber depth, lens thickness and corneal thickness measurements of the internal structure of the eye. The 4Sight is a multi-purpose diagnostic ophthalmic ultrasound system intended to make axial length, anterior chamber depth, lens thickness and corneal thickness measurements of the eye and visualize the internal structure of the eye. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic

The 4sight device is designed to combine the functionalities of Accutome's A-scan Plus (K123349), B-scan Plus (K070943) and Accupach Pachymeter (K042752) devices into a combined, stand-alone platform. The device performs axial length measurements, corneal thickness measurements and images the internal structure of the eye using these 3 modalities. The 4Sight is a stand-alone system which runs on a Windows 8 platform consisting of a 4Sight control unit, transducers, footswitch, and keyboard.

An AccuTip Cover is applied over the tip of a handheld tonometer prior to performing tonometry. The tip cover is used for protection of the patient's eye and the instrument tip. The AccuTip Cover is intended to be used in conjunction with a handheld tonometer by trained individuals experienced in taking intraocular pressure measurements.

The AccuTip Cover is a non-sterile, sanitized, single use latex disposable. It is used to cover the tip of a handheld tonometer.

This instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It also is used for calculating the optical power of the IOL to be implanted during cataract surgery.

The Accutome A-Scan Plus Connect device is designed as a biometer, which uses pulsed echo ultrasound to measure the axial length, and the location of other structures of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a one-dimensional display of returning pulse echoes, with positive peaks to indicate the location of ocular structures. The distance between peaks can be measured. The new A-Scan Plus Connect model uses the personal computer as the main computing vehicle and display instead of the dedicated computer/display of the predicate device. The software modifications in the Connect model are those necessary to interface the processing, data storage, display, and printing capabilities of the personal computer. The A-Scan Plus connect control unit is an interface between the ultrasonic probe and a personal computer. It consists of a microprocessor based printed circuit board, with USB connections, enclosed in a plastic case. The energy source for the A-Scan Plus Connect is USB power from the personal computer instead of the AC to DC adapter used to power the predicate device.

The UBM Plus is designed for imaging the internal structure of the eye including opaque media and anterior segment pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye.

The UBM Plus device is designed as a high frequency ultrasound B-Scan, which uses pulsed echo ultrasound to image the anterior segment of the eye. It utilizes a noncontact probe via a contact Scleral shell to generate and receive the ultrasound pulses, and provides a graphic display of returning pulse echoes to indicate the various structures.

The instrument is used for measuring the corneal thickness of the eye.

The PachPen device is designed as an ultrasound pachymeter which uses pulsed echo ultrasound to measure the corneal thickness of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a numeric display of returning pulse echoes to indicate the thickness of the cornea.

The instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It also is used for calculating the optical power of the IOL to be implanted during cataract surgery.

The AccuSonic A-Scan device is designed as a biometer, which uses pulsed echo ultrasound to measure the axial length, and the location of other structures of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a one-dimensional display of returning pulse echoes, with positive peaks to indicate the location of ocular structures. The distance between peaks can be measured.