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FDA 510(k)

IVUE WITH NORMATIVE DATABASE

K-Number: K121739 · 2013-01-18

ApplicantOptovue, Inc.
Decision Date2013-01-18
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IVUE WITH NORMATIVE DATABASE is the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2013-01-18 under 510(k) number K121739. 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 IVUE WITH NORMATIVE DATABASE?

IVUE WITH NORMATIVE DATABASE is a medical device that received FDA 510(k) clearance on 2013-01-18. The listed applicant is Optovue, Inc.. The 510(k) number is K121739.

When did IVUE WITH NORMATIVE DATABASE receive FDA 510(k) clearance?

IVUE WITH NORMATIVE DATABASE received FDA 510(k) clearance on 2013-01-18, under 510(k) number K121739.

Who is the listed applicant for IVUE WITH NORMATIVE DATABASE?

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 IVUE WITH NORMATIVE DATABASE?

The FDA product code for IVUE WITH NORMATIVE DATABASE 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 SoftwareK130656IFUSIONK122572ICAM FUNDUS CAMERA

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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. KGK120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems Corp.K103266ISTANDOptovue, Inc.

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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