Non-Mydriatic Retinal Camera TRC-NW8F
FDA 510(k)Class II (US FDA 510(k))
by Topcon Corp.
Identifiers
- 510(k) Number
- K100207 FDA 510(k)
- FDA Product Code
- HKI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1120 FDA 510(k)
- Regulation Number
- 886.1120 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Non-Mydriatic Retinal Camera TRC-NW8F is a non-mydriatic ophthalmic imaging device designed for capturing high-resolution color and monochrome images of the retina and anterior segment without pupil dilation. It incorporates a 16.2-megapixel camera system to facilitate detailed retinal visualization, supporting diagnostic evaluations in ophthalmology. This device is classified as an ac-powered ophthalmic camera under regulatory frameworks and is intended for clinical use in retinal imaging procedures.
The TRC-NW8F is supplied as a reusable medical device, intended for use in clinical settings such as ophthalmology clinics or hospitals. It operates under standard electrical power and is not classified as MRI-safe or MRI-conditional. The device is authorized for use following FDA 510(k) clearance under the Traditional pathway, with a classification of Class II. No specific sterility or single-use designation is indicated, and storage conditions are not detailed in the provided data.
Frequently asked questions
What is the primary use of the Topcon TRC-NW8F Non-Mydriatic Retinal Camera?
The TRC-NW8F is designed for capturing high-resolution color and monochrome images of the retina and anterior segment without requiring pupil dilation. This makes it particularly useful for diagnostic evaluations in ophthalmology, allowing clinicians to visualize retinal details for accurate assessments.
Is the TRC-NW8F a single-use or reusable device?
The TRC-NW8F is classified as a reusable medical device. It is intended for repeated use in clinical settings such as ophthalmology clinics or hospitals, provided proper maintenance and cleaning protocols are followed.
What power source does the TRC-NW8F use?
The TRC-NW8F operates using standard electrical power (ac-powered). It is not designed for portable use or battery operation, and it is not classified as MRI-safe or MRI-conditional.
What regulatory pathway was followed for FDA clearance of the TRC-NW8F?
The TRC-NW8F received FDA clearance under the Traditional 510(k) pathway, with a classification of Class II. The device was deemed substantially equivalent to a predicate product through this process, ensuring compliance with regulatory standards for ophthalmic imaging devices.
Does the TRC-NW8F require any special storage conditions?
The provided data does not specify any special storage conditions for the TRC-NW8F. However, as a reusable medical device, it should be stored in a clean, dry environment and protected from physical damage or contamination to maintain its functionality and hygiene.
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: TRC-NW8 Series - Topcon Healthcare, TOPCON TRC-NW8F INSTRUCTION MANUAL Pdf Download, TOPCON TRC-NW8 INSTRUCTION MANUAL Pdf Download | ManualsLib, TRC-NW8F - Top Ophthalmic Products & Services Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100207 | Class II | Active |
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Manufacturer
- Manufacturer
- Topcon Corp.
Sources (1)
- FDA 510(k) K100207 24 fields · synced Oct 1, 2026