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FDA 510(k)

BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM

K-Number: K063343 · 2006-12-13

ApplicantBioptigen, Inc.
Decision Date2006-12-13
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bioptigen, Inc.. It received FDA 510(k) clearance on 2006-12-13 under 510(k) number K063343. 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 BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM?

BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-13. The listed applicant is Bioptigen, Inc.. The 510(k) number is K063343.

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

BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM received FDA 510(k) clearance on 2006-12-13, under 510(k) number K063343.

Who is the listed applicant for BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM?

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 BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM?

The FDA product code for BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM is HLI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 4400K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)

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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