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FDA 510(k)

RTA RETINAL THICKNESS ANALYZER

K-Number: K964137 · 1997-02-03

ApplicantTalia Technology , Ltd.
Decision Date1997-02-03
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RTA RETINAL THICKNESS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Talia Technology , Ltd.. It received FDA 510(k) clearance on 1997-02-03 under 510(k) number K964137. 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 RTA RETINAL THICKNESS ANALYZER?

RTA RETINAL THICKNESS ANALYZER is a medical device that received FDA 510(k) clearance on 1997-02-03. The listed applicant is Talia Technology , Ltd.. The 510(k) number is K964137.

When did RTA RETINAL THICKNESS ANALYZER receive FDA 510(k) clearance?

RTA RETINAL THICKNESS ANALYZER received FDA 510(k) clearance on 1997-02-03, under 510(k) number K964137.

Who is the listed applicant for RTA RETINAL THICKNESS ANALYZER?

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

What is the FDA product code for RTA RETINAL THICKNESS ANALYZER?

The FDA product code for RTA RETINAL THICKNESS ANALYZER 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.

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Other records listing Talia Technology , Ltd. 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.

K061674RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZERK041290RTA MODEL D RETINAL THICKNESS ANALYZERK031312RTA MODEL D RETINAL THICKNESS ANALYZERK000731MODIFICATION TO RTA RETINAL THICKNESS ANALYZERK930518TALIA LASER SLIT

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

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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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