Optina-4C (MHRC-C1N)

• K Number: K250770
• Device Name: Optina-4C (MHRC-C1N)
• Manufacturer: Optina Diagnostics Inc.
• Date Cleared: 2025-09-04 ( 175 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.