Resolve Fundus Camera
Optain Health, Inc.The Resolve Fundus Camera by Optain Health, Inc. is an automatic eye-fundus camera designed to take high-quality digital images of the retina with or without pupil dilation. It uses infrared tracking and autofocus to capture clear images that aid clinicians in evaluating ocular health. The device enhances diagnosis and monitoring of eye conditions by providing precise, easily accessible retinal images.
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.
Technology
The fundus camera uses three internal imaging systems including illumination, imaging, and observation systems. It uses infrared cameras to detect and track the pupil, determines the precise location of the ocular fundus, and employs a charge-coupled device (CCD) to automatically capture images via a main camera. Autofocus is achieved using a beam splitter and LED white light illumination for clear imaging. Auto alignment and auto focus algorithms enable precise and automatic image capture of the left and right retina sequentially.
Performance
Non-clinical testing demonstrated that the device met all design specifications and is substantially equivalent to the predicate device. Testing included electrical safety, electromagnetic compatibility, biocompatibility, optical safety, usability, and software validation following recognized standards such as IEC 60601-1, ANSI Z80.36, ISO 10993 series, and ISO 10940. Performance testing supports the device's safety and effectiveness for retinal imaging.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/6/2025
1 month - 2
FDA Approval
4/30/2025
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