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FDA 510(k)

GLAUCOMA-SCOPE

K-Number: K913118 · 1991-10-09

ApplicantOphthalmic Imaging Systems
Decision Date1991-10-09
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GLAUCOMA-SCOPE 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 1991-10-09 under 510(k) number K913118. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLAUCOMA-SCOPE?

GLAUCOMA-SCOPE is a medical device that received FDA 510(k) clearance on 1991-10-09. The listed applicant is Ophthalmic Imaging Systems. The 510(k) number is K913118.

When did GLAUCOMA-SCOPE receive FDA 510(k) clearance?

GLAUCOMA-SCOPE received FDA 510(k) clearance on 1991-10-09, under 510(k) number K913118.

Who is the listed applicant for GLAUCOMA-SCOPE?

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 GLAUCOMA-SCOPE?

The FDA product code for GLAUCOMA-SCOPE is HLI.

Related Clinical Trials

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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.

K110006OIS SYMPHONY IMAGE MANAGMENT SYSTEMK092374OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCANK982689WINSTATION RETINAL IMAGERK913929DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM

Related Devices (Code: HLI)

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.

K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.K123316HEINE OMEGA 500Heine Optotechnik GmbH & Co. KGK121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems Corp.

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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