MiiS Horus Eye Anterior Camera
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- MiiS EUDAMED
- Device Name
- Image Management Platform EUDAMED
- Model / Reference
- SA 1 EUDAMEDModel: SA 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872717034 EUDAMED
- Basic UDI-DI
- 471987271700095 EUDAMED
- Direct Marketing DI
- 04719872717034 EUDAMED
- 510(k) Number
- K193188 FDA 510(k)
- FDA Product Code
- HJO FDA 510(k)
- EMDN Code
- Z12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1850 FDA 510(k)
- Regulation Number
- 886.1850 FDA 510(k)
- Market of Registration
- France EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The MiiS Horus Eye Anterior Camera is a digital, hand-held slit-lamp system classified as a biomicroscope. It provides noninvasive illumination, magnification, and visualization of the anterior segment of the human eye, including the cornea, anterior chamber, and lens, while enabling digital photography and video recording.
This device is intended for use in ophthalmic settings and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance and MDR authorisation, adhering to regulatory standards for Class II devices under regulation number 886.1850. The system operates on AC power and is designed for clinical examination and diagnostic imaging of the eye’s anterior segment.
Frequently asked questions
Is the MiiS Horus Eye Anterior Camera designed for single-use or reusable in clinical settings, and what does this mean for maintenance and cleaning procedures?
The MiiS Horus Eye Anterior Camera is explicitly supplied as a reusable medical instrument, meaning it is intended for repeated use across multiple patients. As a reusable device, proper cleaning, disinfection, and maintenance procedures must be followed to ensure sterility and functionality between uses. The manufacturer’s instructions should be consulted for specific protocols, as improper handling could compromise diagnostic accuracy or introduce infection risks.
What specific parts of the eye can the MiiS Horus Eye Anterior Camera visualize, and how does its digital functionality enhance clinical assessments?
The device is designed to provide noninvasive illumination, magnification, and visualization of the anterior segment of the eye, including the cornea, anterior chamber, and lens. Its digital capabilities allow for photography and video recording, which enhances clinical assessments by enabling permanent documentation of findings, sharing with specialists, and longitudinal monitoring of conditions like cataracts, corneal diseases, or glaucoma.
Does the MiiS Horus Eye Anterior Camera require any special power source, and how does this affect its portability or setup in a clinical environment?
The device operates on AC power, meaning it must be plugged into a standard electrical outlet for use. This design choice ensures stable performance but may limit its portability compared to battery-powered alternatives. Clinicians should plan for a dedicated power source during examinations, though the hand-held design allows for flexibility in positioning around the patient.
What regulatory pathways has the MiiS Horus Eye Anterior Camera followed, and how does this impact its use in different global markets?
The device has received FDA 510(k) clearance and MDR authorization, confirming compliance with regulatory standards for Class II medical devices (regulatory number 886.1850). This dual approval allows it to be legally marketed in the U.S. and EU, though clinicians should verify local compliance requirements, such as additional country-specific certifications or labeling adjustments, before use in other regions.
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: MiiS Horus Eye Anterior Camera (K193188) — FDA 510 (k) | Innolitics, MiiS - Medimaging Integrated Solution Inc., MiiS Horus Eye Anterior Camera - BEUDAMED
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 | K193188 | Class II | Active |
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Manufacturer
- Manufacturer
- Medimaging Integrated Solution, Inc (Miis)
Sources (2)
- FDA 510(k) K193188 24 fields · synced Sep 18, 2026
- EUDAMED e993ea36-927e-426d-9b4f-542f7b4a93f1 61 fields · synced Jul 21, 2026