NFC-700 Non-Mydriatic Auto Fundus Camera
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182199 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 NFC-700 Non-Mydriatic Auto Fundus Camera is an ophthalmic imaging device designed for automated retinal photography without pupil dilation. It captures high-resolution images of the retina, enabling non-invasive assessment of the fundus for diagnostic and monitoring purposes in clinical settings.
This device is intended for use in ophthalmic examinations and is supplied as a reusable medical instrument. It operates on AC power and is classified as a Class II device under FDA regulations, with FDA 510(k) clearance and MDR authorization. The camera requires proper calibration and maintenance in a controlled clinical environment to ensure accurate and reliable imaging results.
Frequently asked questions
What is the primary purpose of the NFC-700 non-mydriatic auto fundus camera in clinical settings?
The NFC-700 is designed for automated retinal photography without requiring pupil dilation, enabling non-invasive assessment of the retina. This makes it ideal for capturing high-resolution images of the fundus for diagnostic and monitoring purposes in ophthalmic examinations.
Is the NFC-700 non-mydriatic auto fundus camera single-use or reusable, and what does this mean for maintenance?
The NFC-700 is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings. Proper calibration and maintenance are required to ensure accurate and reliable imaging results, as specified in the manufacturer’s instructions for use.
How is the NFC-700 powered, and does this affect its portability or setup requirements?
The NFC-700 operates on AC power, which means it requires a stable electrical outlet for use. This design does not make it portable for on-site or mobile examinations but ensures consistent performance in controlled clinical environments.
What regulatory pathways has the NFC-700 non-mydriatic auto fundus camera followed, and what does this imply for compliance?
The device has obtained FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for Class II medical devices in the U.S. and EU markets. This implies compliance with strict manufacturing, performance, and safety requirements for ophthalmic imaging equipment.
Are there different models or configurations of the NFC-700, and how might this affect selection for a clinical practice?
The provided data lists multiple registration numbers and product codes (e.g., 3004441848, 1000391004), which may correspond to variations or configurations of the NFC-700. While exact differences aren’t detailed, these identifiers suggest potential customization for different clinical needs, such as imaging resolution or software features. Consulting the manufacturer would clarify specific model distinctions.
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.
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 | K182199 | Class II | Active |
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Manufacturer
- Manufacturer
- Crystalvue Medical Corporation
Sources (2)
- FDA 510(k) K182199 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026