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FDA 510(k)

3D OCT-1 Maestro

K-Number: K161509 · 2016-07-28

ApplicantTopcon Corporation
Decision Date2016-07-28
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

3D OCT-1 Maestro is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161509. 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 OCT-1 Maestro?

3D OCT-1 Maestro is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Topcon Corporation. The 510(k) number is K161509.

When did 3D OCT-1 Maestro receive FDA 510(k) clearance?

3D OCT-1 Maestro received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161509.

Who is the listed applicant for 3D OCT-1 Maestro?

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 OCT-1 Maestro?

The FDA product code for 3D OCT-1 Maestro is OBO.

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 SystemK2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))K232828IMAGEnet6 Ophthalmic Data SystemK2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)K221111Non-Mydriatic Retinal Camera NW500

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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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