Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HUMPHREY OCT SCANNER

K-Number: K961171 · 1996-06-21

ApplicantCarl Zeiss, Inc.
Decision Date1996-06-21
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HUMPHREY OCT SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss, Inc.. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K961171. 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 HUMPHREY OCT SCANNER?

HUMPHREY OCT SCANNER is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K961171.

When did HUMPHREY OCT SCANNER receive FDA 510(k) clearance?

HUMPHREY OCT SCANNER received FDA 510(k) clearance on 1996-06-21, under 510(k) number K961171.

Who is the listed applicant for HUMPHREY OCT SCANNER?

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

What is the FDA product code for HUMPHREY OCT SCANNER?

The FDA product code for HUMPHREY OCT SCANNER 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 Carl Zeiss, 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.

K013402VISULAS 532SK003885VISULAS YAG IIK993357IOLMASTERK983868OPMI TWINER SURGICAL MICROSCOPEK965139SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEMK961380CPC PROBE

View all 44 devices →

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.

↑