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FDA 510(k)

ISTAND

K-Number: K103266 · 2011-06-03

ApplicantOptovue, Inc.
Decision Date2011-06-03
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ISTAND is the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2011-06-03 under 510(k) number K103266. 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 ISTAND?

ISTAND is a medical device that received FDA 510(k) clearance on 2011-06-03. The listed applicant is Optovue, Inc.. The 510(k) number is K103266.

When did ISTAND receive FDA 510(k) clearance?

ISTAND received FDA 510(k) clearance on 2011-06-03, under 510(k) number K103266.

Who is the listed applicant for ISTAND?

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

What is the FDA product code for ISTAND?

The FDA product code for ISTAND is HLI.

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Other records listing Optovue, Inc. 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.

K222166SOLIXK180660AvantiK163475iVueK153080RTVue XR OCT Avanti with AngioVue SoftwareK130656IFUSIONK121739IVUE WITH NORMATIVE DATABASE

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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

View on FDA Database →

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

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