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U.S. Department of Health and Human Services

Product Classification

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Device camera, ophthalmic, slit-scanning
Regulation Description Ophthalmic camera.
Definition An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Physical State Slit-scanning cameras consist of an incoherent light source, image forming lens, slit forming optics, scanner, an image sensor, and image reconstruction software.
Technical Method The imaging plane is scanned by a rectangular slit of non-coherent light and reflected images of the illuminated areas are sequentially captured by an imaging sensor. An ophthalmic image is reconstructed from individual slit images in software.
Target Area Eye and ocular tissues (anterior and posterior segment).
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeQER
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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