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FDA 510(k)

DRI OCT Triton

K-Number: K173119 · 2018-01-19

ApplicantTopcon Corporation
Decision Date2018-01-19
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DRI OCT Triton is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K173119. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI OCT Triton?

DRI OCT Triton is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Topcon Corporation. The 510(k) number is K173119.

When did DRI OCT Triton receive FDA 510(k) clearance?

DRI OCT Triton received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173119.

Who is the listed applicant for DRI OCT Triton?

The FDA 510(k) record lists Topcon Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRI OCT Triton?

The FDA product code for DRI OCT Triton is OBO.

Other records listing Topcon Corporation as applicant

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Related Devices (Code: OBO)

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.

K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey CorporationK250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbHK241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH

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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