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510(k) Data Aggregation
K Number
K193319Device Name
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
Manufacturer
Date Cleared
2020-06-01
(182 days)
Product Code
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
Vasoptic Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XyCAM RI System is intended to capture, store, and display images of dynamic blood flow changes in the human retina, and to provide quantitative outputs of relative blood flow information.
Device Description
The XyCAM™ RI System (or XyCAM RI) is a non-invasive retinal blood flow imaging device. It generates images of one or more regions of the retina by using an imaging technique called Laser Speckle Contrast Imaging (LSCI). This technique utilizes a lowintensity laser beam to illuminate the back of the eye and a high-speed, high-sensitivity camera to acquire a stack of images. The captured image stack is then processed such that the intensity at every image pixel is processed in conjunction with the intensities of other spatio-temporally adjacent pixels to obtain a speckle contrast value at the said pixel. which is indicative of blood flow velocity at the said pixel. Accordingly, the XyCAM RI is able to generate and display a map of Blood Flow Velocity indices within the imaged field of view.
The XyCAM RI System consists of following modules:
- The XyCAM RI contains a module to provide illumination to the back of the eye, various optical components to manipulate light along the illumination and imaging path, a high-speed camera to capture images, visual targets for the imaged subject to fixate his/her gaze on during imaging, and electronic and mechanical components for control and operation.
- System PC contains the XyCAM RI Software. The Operator uses the XyCAM RI System PC keyboard, mouse, and monitor to interact with the XyCAM RI Software, which controls the XyCAM RI operation including management of user and patient information, control of image acquisition, facilitation of image analysis, and generation of imaging results.
- Accessories include an imager station and an external hard drive.
- A pulse oximeter is included as an optional third-party device.
The XyCAM RI Software outputs Blood Flow Velocity indices (arbitrary units) that can be assessed for spatial and temporal trends in user defined regions.
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