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510(k) Data Aggregation
K Number
K250683Device Name
Resolve Fundus Camera
Manufacturer
Optain Health, Inc.
Date Cleared
2025-04-30
(55 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
Optain Health, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
Device Description
The Resolve Fundus Camera is a fundus camera designed to perform fundus observation, automatic pupil tracking and focusing, automatic image capture, and image preservation. The Resolve Fundus Camera is used for non-mydriatic observation and capturing of retinal images. The fundus camera employes three internal imaging systems to operate: illumination system, imaging system and observation system. Auto-alignment and auto-focus algorithms are used to automatically find and capture desired images of the fundus.
The fundus camera features an internal, movable three-dimensional platform that allows for switching and precise positioning of the left and right eyes. The imaging process is done one eye at a time (left eye and then the right eye). The internal, moveable three-dimensional platform contains two types of cameras: a set of infrared cameras (one on each side) as well as one main camera.
The observation system is used to detect and track the patient's pupil. Next, the illumination system determines the precise location of the ocular fundus after the pupil is located by the observation system. The system precisely finds the relationship between the position of the ocular fundus at different diopters, and the lens of the main camera.
Once the location of the fundus is found, a charge-coupled device (CCD) automatically captures a still image of the fundus through the main camera. The autofocus system utilizes a beam splitter to split a beam of light into two fine beams, which then image the ocular fundus onto the CCD. When the focus is at its sharpest position, the split beams align horizontally. At this point, the LED white light illumination system, installed in the imaging module on the three-dimensional movable platform, emits uniform white light of appropriate intensity to illuminate the ocular fundus. The imaging system captures the fundus information onto the CCD, and the received signals are displayed in real-time on a liquid crystal display (LCD) through the control system. Doctors can visually assess the patient's ocular fundus on the LCD screen.
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