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510(k) Data Aggregation
K Number
K243664Device Name
Sentinel Camera
Manufacturer
AI Optics
Date Cleared
2024-12-17
(20 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
AI Optics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sentinel Camera is a non-mydriatic medical digital camera that is intended to capture digital images of the human eye.
Device Description
The Sentinel Camera is accompanied by the following accessories: a charging base, eye cup, and power cable. The Sentinel Camera is designed for use in a medical environment. Captured images are used for documentation and consultation. Sentinel Camera has internal memory where captured images are stored. The Sentinel Camera is designed for non-mydriatic retinal imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the retina and white light is flashed when an image is taken. The pupil does not respond to the infrared light, so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. The Sentinel Camera has three internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The left and right fixation targets provide disc-centered images. The transfer of images to the AI Optics Server is carried out via Wi-Fi communication. The Sentinel Camera has a rechargeable Li-ion battery that is charged when the camera is placed on charging base, which is connected to the mains by the power cable.
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