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FDA 510(k)

OVision Imaging System

K-Number: K200275 · 2020-03-03

ApplicantOphthalmic Labs, Inc.
Decision Date2020-03-03
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OVision Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmic Labs, Inc.. It received FDA 510(k) clearance on 2020-03-03 under 510(k) number K200275. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVision Imaging System?

OVision Imaging System is a medical device that received FDA 510(k) clearance on 2020-03-03. The listed applicant is Ophthalmic Labs, Inc.. The 510(k) number is K200275.

When did OVision Imaging System receive FDA 510(k) clearance?

OVision Imaging System received FDA 510(k) clearance on 2020-03-03, under 510(k) number K200275.

Who is the listed applicant for OVision Imaging System?

The FDA 510(k) record lists Ophthalmic Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OVision Imaging System?

The FDA product code for OVision Imaging System is NFJ.

Related Devices (Code: NFJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260694ZEISS CLINIC 360Carl Zeiss Meditec, AGK253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA OyK234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 Ophthalmic Data SystemTopcon CorporationK232944CALLISTO eyeCarl Zeiss Meditec, AGK232555HarmonyTopcon Healthcare Solutions

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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