Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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); IMAGEnet6 Ophthalmic Data System

K-Number: K241081 · 2024-07-17

ApplicantTopcon Corporation
Decision Date2024-07-17
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2024-07-17 under 510(k) number K241081. 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); IMAGEnet6 Ophthalmic Data System?

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System is a medical device that received FDA 510(k) clearance on 2024-07-17. The listed applicant is Topcon Corporation. The 510(k) number is K241081.

When did 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System receive FDA 510(k) clearance?

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System received FDA 510(k) clearance on 2024-07-17, under 510(k) number K241081.

Who is the listed applicant for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System?

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); IMAGEnet6 Ophthalmic Data System?

The FDA product code for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System 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.

NCT07641738Collecting Data on Retinal Blood Blood Flow and Blood Vessel Shape/Appearance Using an Investigational Device, XyCAM CRE, and to Then Compare Those Images With Images Collected From a Patient's Routine Clinical Examination.NOT_YET_RECRUITINGNCT05844852P200TE US Reference Database StudyCOMPLETEDNCT07652931Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory ConcernsNOT_YET_RECRUITINGNCT07713069OCT-PRO Model vs. Clinicians: Cataract Surgery Outcome PredictionNOT_YET_RECRUITINGNCT07733154AI-Driven IOL Prediction Using SS-OCT BiometryNOT_YET_RECRUITINGNCT07741370Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens DiseasesACTIVE_NOT_RECRUITING

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 OMNIAK2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))K232828IMAGEnet6 Ophthalmic Data SystemK2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)K221111Non-Mydriatic Retinal Camera NW500K173119DRI OCT Triton

View all 11 devices →

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.

↑