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FDA 510(k)

ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)

K-Number: K120057 · 2012-05-11

ApplicantBioptigen, Inc.
Decision Date2012-05-11
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) is the device name listed in this FDA 510(k) record. The listed applicant is Bioptigen, Inc.. It received FDA 510(k) clearance on 2012-05-11 under 510(k) number K120057. 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 ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)?

ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) is a medical device that received FDA 510(k) clearance on 2012-05-11. The listed applicant is Bioptigen, Inc.. The 510(k) number is K120057.

When did ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) receive FDA 510(k) clearance?

ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) received FDA 510(k) clearance on 2012-05-11, under 510(k) number K120057.

Who is the listed applicant for ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)?

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

What is the FDA product code for ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)?

The FDA product code for ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) is HLI.

Related Clinical Trials

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Other records listing Bioptigen, 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.

K162783EnFocus 2300, EnFocus 4400K063343BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC 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.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems Corp.K103266ISTANDOptovue, Inc.

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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