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)

TOPOGRAPHIC SCANNING SYSTEM TOPSS

K-Number: K923742 · 1993-03-26

ApplicantCarl Zeiss Meditec, Inc.
Decision Date1993-03-26
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TOPOGRAPHIC SCANNING SYSTEM TOPSS is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 1993-03-26 under 510(k) number K923742. 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 TOPOGRAPHIC SCANNING SYSTEM TOPSS?

TOPOGRAPHIC SCANNING SYSTEM TOPSS is a medical device that received FDA 510(k) clearance on 1993-03-26. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K923742.

When did TOPOGRAPHIC SCANNING SYSTEM TOPSS receive FDA 510(k) clearance?

TOPOGRAPHIC SCANNING SYSTEM TOPSS received FDA 510(k) clearance on 1993-03-26, under 510(k) number K923742.

Who is the listed applicant for TOPOGRAPHIC SCANNING SYSTEM TOPSS?

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

What is the FDA product code for TOPOGRAPHIC SCANNING SYSTEM TOPSS?

The FDA product code for TOPOGRAPHIC SCANNING SYSTEM TOPSS 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 Meditec, 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.

K243878CLARUS (700)K233933CIRRUS™ HD-OCT Model 6000K230350VISULAS yagK231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)K222200CIRRUS HD-OCTK191194CLARUS

View all 27 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.

↑