Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Softwar…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221320 FDA 510(k)
- FDA Product Code
- OBO FDA 510(k)
- Models / Variants
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 Scanning Laser Ophthalmoscope Mirante is a diagnostic imaging device designed for retinal examination. It combines scanning laser ophthalmoscopy (SLO) with optical coherence tomography (OCT) in the SLO/OCT model, enabling high-resolution imaging of the retina and its layers. This technology facilitates detailed visualization of retinal structures, aiding in the assessment of retinal diseases and conditions.
The device is supplied as a reusable medical instrument intended for use in ophthalmic clinical settings. It operates with the NAVIS-EX image filing software for documentation and analysis. The Mirante is classified under FDA 510(k) and EU MDR regulations, with a device classification of Class II (Ophthalmic). No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
What are the key differences between the SLO and SLO/OCT models of the Mirante Scanning Laser Ophthalmoscope?
The SLO model provides scanning laser ophthalmoscopy for high-resolution retinal imaging, while the SLO/OCT model combines this with optical coherence tomography (OCT). The OCT capability in the SLO/OCT version allows for cross-sectional imaging of retinal layers, offering deeper structural analysis beyond what the SLO alone provides. Both models use the NAVIS-EX software for documentation and analysis.
Is the Mirante Scanning Laser Ophthalmoscope reusable or single-use, and what does that mean for my clinic’s workflow?
The Mirante is designed as a reusable medical instrument, meaning it is intended for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. This makes it suitable for high-volume ophthalmic practices, as it can be shared across multiple patients with appropriate sterilization protocols (though specific sterility claims are not provided in the data). Clinics must follow manufacturer guidelines for reprocessing to ensure safety and performance.
What software is included with the Mirante, and how does it support clinical workflows?
The Mirante comes with the NAVIS-EX image filing software, which is specifically designed for documenting and analyzing retinal images captured by the device. This software likely enables storage, retrieval, and sharing of imaging data, as well as basic analysis tools to assist in diagnosing retinal conditions. It integrates seamlessly with the hardware to streamline workflows in ophthalmic clinics.
Are there multiple sizes or models of the Mirante, and how do I determine which one fits my clinic’s needs?
The data indicates two primary models: the SLO model (for standard retinal imaging) and the SLO/OCT model (which adds cross-sectional OCT imaging). While specific size variations aren’t detailed, the choice depends on whether your clinic requires the additional diagnostic depth of OCT. The SLO/OCT model is ideal for advanced retinal assessments, while the SLO model may suffice for basic retinal examinations. Consulting with Nidek’s sales team can help tailor the selection to your practice’s needs.
How is the Mirante regulated, and what does that mean for compliance in my facility?
The Mirante is classified under FDA 510(k) and EU MDR regulations, with a Class II (Ophthalmic) designation in the U.S. This means it has undergone premarket review to ensure safety and effectiveness for its intended use in retinal imaging. Facilities using it must adhere to standard medical device compliance protocols, including proper training, maintenance, and documentation as outlined by the manufacturer and regulatory bodies. The device’s classification also implies routine inspections may apply, depending on local healthcare regulations.
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: How to scan with an HP printer | HP® Support, IJ Scan Utility (Windows) - Scanning Documents and Photos, Scanner - Quick and Easy Document Scanning - Free download and …
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 | K221320 | Class II | Active |
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Manufacturer
- Manufacturer
- Nidek Co., Ltd.
Sources (2)
- FDA 510(k) K221320 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026