Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Topcon Corporation. It received FDA 510(k) clearance on 2024-04-10 under approval 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. It is manufactured by Topcon Corporation. The 510(k) number is K233561.

When was 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) approved by the FDA?

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

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

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) is manufactured by Topcon Corporation.

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

NCT06797765 Optical Coherence Tomography Angiography in Neurological Disease COMPLETED NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED NCT05493904 PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX) ACTIVE_NOT_RECRUITING NCT04995341 Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) RECRUITING NCT05904028 Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD RECRUITING NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING

Other Devices by Topcon Corporation

K161972Slit Lamp SL-D301 K1615093D OCT-1 Maestro K171370IMAGEnet 6 Ophthalmic Data System K1701643D OCT-1 Maestro K173119DRI OCT Triton K221111Non-Mydriatic Retinal Camera NW500

View all 11 devices →

Related Devices (Code: OBO)

K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc. K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. K1615093D OCT-1 MaestroTopcon Corporation K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorHeidelberg Engineering GmbH K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorHeidelberg Engineering GmbH K163195PRIMUSCarl Zeiss Suzhou Co., Ltd.

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.

↑