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FDA 510(k)

RTA MODEL D RETINAL THICKNESS ANALYZER

K-Number: K031312 · 2003-05-06

ApplicantTalia Technology , Ltd.
Decision Date2003-05-06
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RTA MODEL D 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 2003-05-06 under 510(k) number K031312. 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 MODEL D RETINAL THICKNESS ANALYZER?

RTA MODEL D RETINAL THICKNESS ANALYZER is a medical device that received FDA 510(k) clearance on 2003-05-06. The listed applicant is Talia Technology , Ltd.. The 510(k) number is K031312.

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

RTA MODEL D RETINAL THICKNESS ANALYZER received FDA 510(k) clearance on 2003-05-06, under 510(k) number K031312.

Who is the listed applicant for RTA MODEL D 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 MODEL D RETINAL THICKNESS ANALYZER?

The FDA product code for RTA MODEL D RETINAL THICKNESS ANALYZER is HLI.

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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 ANALYZERK000731MODIFICATION TO RTA RETINAL THICKNESS ANALYZERK964137RTA 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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