Retinal Functional Imager (RFI)
510(k) K062416
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062416 | Date17 Nov 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HKI
- FDA applicant
- Optical Imaging , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1120
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Retinal Functional Imager (RFI) is a mydriatic fundus camera designed to capture high-resolution images of the retina under dilated pupil conditions. It provides dynamic visualization of retinal blood flow, including vessel velocity and flow pathways, to assist in the assessment of ophthalmic diseases.
The RFI is supplied as a reusable ophthalmic imaging device, incorporating a digital camera and stroboscopic light source for high-frame-rate retinal imaging. It is intended for use in clinical settings, with no specific regulatory mention of MRI safety or sterility requirements. Authorized under FDA 510(k) clearance (K062416), it falls under Class II medical device classification.
Other devices from Optical Imaging, Ltd.
Questions
AI-generated answers, 19 Sep 2026
Is the Retinal Functional Imager (RFI) designed for single-use or can it be reused in clinical settings?
The RFI is explicitly described as a reusable ophthalmic imaging device. Since it is not labeled as single-use and is intended for clinical settings, it must be properly cleaned, disinfected, and maintained between uses to ensure safety and performance. The manufacturer’s instructions for reuse should be followed strictly.
What types of retinal imaging capabilities does the RFI provide, and how does it differ from a standard fundus camera?
Unlike a standard fundus camera, the RFI captures high-resolution, dynamic images of the retina under dilated pupil conditions. It includes a stroboscopic light source and high-frame-rate imaging to visualize retinal blood flow, vessel velocity, and flow pathways—features that help assess ophthalmic diseases by providing functional, not just structural, insights.
Are there specific storage requirements for the RFI, or can it be stored in a standard clinical environment?
The device data does not specify sterility requirements or unique storage conditions, but as a reusable ophthalmic imaging device, it should be stored in a clean, controlled environment (e.g., a clinical imaging room) to protect it from dust, moisture, or physical damage. The manufacturer’s guidelines should be consulted for optimal preservation, especially if the device has optical or electronic components.
What regulatory pathway was followed for FDA clearance of the RFI, and what does this mean for clinicians?
The RFI received FDA 510(k) clearance (K062416) under a Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This classification places it in Class II, indicating moderate regulatory oversight. Clinicians can rely on this clearance as evidence that the device meets FDA safety and effectiveness standards for its intended use in retinal imaging.