TRC-NW400 Non-Mydriatic Retinal Camera
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141481 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 TRC-NW400 Non-Mydriatic Retinal Camera is an ophthalmic device designed for capturing high-resolution, true-color images of the retina and anterior segment of the eye without pupil dilation. It functions as an automated, autofocus fundus camera, enabling precise and efficient retinal imaging for diagnostic purposes.
This device is supplied as a reusable, non-sterile medical instrument intended for use in clinical ophthalmology settings. It features a 360° rotating touch-panel monitor for intuitive operation and is classified as a Class II medical device under FDA regulations. The TRC-NW400 holds FDA 510(k) clearance and MDR authorization, ensuring compliance with stringent regulatory standards for ophthalmic imaging equipment.
Frequently asked questions
Is the TRC-NW400 Non-Mydriatic Retinal Camera designed for use with dilated pupils, or does it work without pupil dilation?
The TRC-NW400 is specifically designed as a non-mydriatic retinal camera, meaning it captures high-resolution retinal images without requiring pupil dilation. This makes it ideal for routine screening and diagnostic imaging where mydriatics (dilation drops) are avoided, such as in pediatric or general ophthalmology settings.
How is the TRC-NW400 supplied, and is it meant for single-use or reusable applications in a clinical setting?
The TRC-NW400 is supplied as a reusable, non-sterile medical instrument, intended for use in clinical ophthalmology environments. Since it is reusable, it must be properly cleaned, disinfected, and maintained between uses according to manufacturer guidelines to ensure safety and performance.
What type of display does the TRC-NW400 feature, and how does it enhance usability for clinicians?
The TRC-NW400 includes a 360° rotating touch-panel monitor, which allows clinicians to operate the device intuitively from multiple angles. This design improves ergonomics, particularly during retinal imaging, by reducing the need for awkward positioning and enabling better visualization of captured images.
What regulatory pathways has the TRC-NW400 followed, and what does this mean for its compliance and use in the U.S.?
The TRC-NW400 holds FDA 510(k) clearance under a Traditional review pathway (decision code: SESE) and is classified as a Class II medical device for ophthalmic imaging. It also carries MDR authorization, indicating compliance with European regulatory standards. This means the device meets stringent U.S. and EU requirements for safety and performance in retinal imaging.
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-NW400 - Top Ophthalmic Products & Services Corp., Topcon TRC-NW400 Non-Mydriatic Retinal Camera - Ophthalmicmart, PDF TRC-NW400 - Topcon Healthcare
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141481 | Class II | Active |
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Manufacturer
- Manufacturer
- Topcon Corporation
Sources (2)
- FDA 510(k) K141481 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 18, 2026