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FDA 510(k)

OIS SYMPHONY IMAGE MANAGMENT SYSTEM

K-Number: K110006 · 2011-05-18

ApplicantOphthalmic Imaging Systems
Decision Date2011-05-18
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OIS SYMPHONY IMAGE MANAGMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmic Imaging Systems. It received FDA 510(k) clearance on 2011-05-18 under 510(k) number K110006. 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 OIS SYMPHONY IMAGE MANAGMENT SYSTEM?

OIS SYMPHONY IMAGE MANAGMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-18. The listed applicant is Ophthalmic Imaging Systems. The 510(k) number is K110006.

When did OIS SYMPHONY IMAGE MANAGMENT SYSTEM receive FDA 510(k) clearance?

OIS SYMPHONY IMAGE MANAGMENT SYSTEM received FDA 510(k) clearance on 2011-05-18, under 510(k) number K110006.

Who is the listed applicant for OIS SYMPHONY IMAGE MANAGMENT SYSTEM?

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

What is the FDA product code for OIS SYMPHONY IMAGE MANAGMENT SYSTEM?

The FDA product code for OIS SYMPHONY IMAGE MANAGMENT SYSTEM is NFJ.

Related Clinical Trials

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.

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Other records listing Ophthalmic Imaging Systems as applicant

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.

K092374OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCANK982689WINSTATION RETINAL IMAGERK913929DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEMK913118GLAUCOMA-SCOPE

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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