Optical Coherence Tomography 3D OCT-2000
FDA 510(k)Class II (US FDA 510(k))
by Topcon Corp.
Identifiers
- 510(k) Number
- K092470 FDA 510(k)
- FDA Product Code
- OBO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1570 FDA 510(k)
- Regulation Number
- 886.1570 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Optical Coherence Tomography 3D OCT-2000 is a spectral-domain optical coherence tomography system designed for high-resolution imaging of the retina. It provides detailed cross-sectional views of ocular structures, enabling precise assessment of retinal layers, thickness, and morphology for diagnostic and monitoring purposes in ophthalmology.
This device integrates a high-resolution fundus camera and a color touchscreen interface within a compact design. Supplied as a reusable medical instrument, it operates in clinical settings such as ophthalmology departments and is regulated under FDA 510(k) clearance (K092470) as a Class II device (DMEP, 886.1570). Network compatibility allows remote data review via IMAGEnet™ software, facilitating collaborative evaluation and storage of patient imaging data.
Frequently asked questions
What clinical applications does the Optical Coherence Tomography 3D OCT-2000 support in ophthalmology?
The 3D OCT-2000 is designed for high-resolution imaging of retinal structures, enabling detailed cross-sectional views of the retina. Clinicians use it to assess retinal layer thickness, morphology, and structural integrity for diagnostic purposes and ongoing monitoring of ocular conditions, such as diabetic retinopathy, macular degeneration, or glaucoma.
Is the Optical Coherence Tomography 3D OCT-2000 a single-use or reusable device, and how is it maintained?
The 3D OCT-2000 is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings. Since it is not described as disposable, proper cleaning, sterilization, and maintenance protocols must be followed as per manufacturer guidelines to ensure reliability and infection control.
How does the 3D OCT-2000 facilitate collaboration among healthcare providers?
The device integrates network compatibility with Topcon’s IMAGEnet™ software, allowing remote data review. This enables healthcare providers to share and evaluate patient imaging data collaboratively, improving diagnostic accuracy and continuity of care across different locations.
What type of regulatory clearance does the Optical Coherence Tomography 3D OCT-2000 hold in the U.S.?
The 3D OCT-2000 is cleared by the FDA under a 510(k) pathway (K092470) as a Class II device, specifically categorized under DMEP (Durable Medical Equipment, Prosthetics, Orthotics, and Supplies) with product code OBO. This clearance indicates it is deemed substantially equivalent to a predicate device for ophthalmic use.
Does the Optical Coherence Tomography 3D OCT-2000 include a fundus camera, and how does it enhance imaging capabilities?
Yes, the 3D OCT-2000 integrates a high-resolution fundus camera alongside its optical coherence tomography functionality. This combination allows for simultaneous imaging of the retina’s surface and cross-sectional views, providing comprehensive visualization of both retinal structure and pathology for more accurate diagnostics.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Optical Coherence Tomography 3D OCT-2000 - Topcon Healthcare, PDF Optical Coherence Tomography 3D OCT-2000 - mail.topcon.com.hr, PDF Optical Coherence Tomography - RIMC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092470 | Class II | Active |
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Manufacturer
- Manufacturer
- Topcon Corp.
Sources (1)
- FDA 510(k) K092470 24 fields · synced Sep 19, 2026