RETCAM 3 OPHTHALMIC IMAGING SYSTEM

• K Number: K081858
• Device Name: RETCAM 3 OPHTHALMIC IMAGING SYSTEM
• Manufacturer: CLARITY MEDICAL SYSTEMS
• Date Cleared: 2008-11-05 ( 127 days)
• Product Code: HKI
• Regulation Number: 886.1120
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.