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FDA 510(k)

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))

K-Number: K233561 · 2024-04-10

ApplicantTopcon Corporation
Decision Date2024-04-10
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2024-04-10 under 510(k) number K233561. 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 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))?

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Topcon Corporation. The 510(k) number is K233561.

When did 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) receive FDA 510(k) clearance?

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) received FDA 510(k) clearance on 2024-04-10, under 510(k) number K233561.

Who is the listed applicant for 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))?

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 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))?

The FDA product code for 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) is OBO.

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 Topcon Corporation 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.

K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIAK2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data SystemK232828IMAGEnet6 Ophthalmic Data SystemK2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)K221111Non-Mydriatic Retinal Camera NW500K173119DRI OCT Triton

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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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