MiiS Horus Bronchoscope +2 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- MiiS Horus Endoscope Display System EUDAMED
- Device Name
- Bronchoscope EUDAMED
- Model / Reference
- ECB series EUDAMEDEDS 500 EUDAMEDEVS 700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872715283 EUDAMED04719872715290 EUDAMED
- Basic UDI-DI
- 47198727150028T EUDAMED
- Direct Marketing DI
- 04719872715283 EUDAMED04719872715290 EUDAMED
- 510(k) Number
- K234113 FDA 510(k)
- FDA Product Code
- EOQ FDA 510(k)
- EMDN Code
- Z12020880 PULMONARY ENDOSCOPIC INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Ear, Nose, Throat 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 Bronchoscope is a flexible endoscope designed for visualizing internal airways and cavities, particularly within the respiratory and upper gastrointestinal tracts. This device integrates advanced imaging technology to provide real-time visualization, aiding in diagnostic and therapeutic procedures such as bronchoscopy. The accompanying Endoscope Display System—available as a Tablet or Video Box—enables high-resolution image capture and streaming, enhancing clinical workflows with portable and adaptable display options. Its modular design supports both bronchoscope and endoscope applications, ensuring versatility in procedural settings.
The MiiS Horus Bronchoscope and its display systems are intended for use in clinical environments, including operating rooms, endoscopy suites, and intensive care units. The bronchoscope is supplied as a reusable device, requiring adherence to manufacturer cleaning and sterilization protocols to maintain performance and safety. The display systems are non-sterile, single-use accessories designed for MRI-safe operation, ensuring compatibility with magnetic resonance imaging environments. Regulatory clearance includes FDA 510(k) approval under the Ear, Nose, and Throat advisory committee, with additional compliance under the EU Medical Device Regulation (MDR).
Frequently asked questions
Is the MiiS Horus Bronchoscope reusable, and if so, what cleaning and sterilization steps are required?
Yes, the MiiS Horus Bronchoscope is designed for reuse. To maintain safety and performance, it must be cleaned and sterilized according to the manufacturer’s specified protocols. These protocols typically include thorough disinfection followed by high-level sterilization, such as steam sterilization or chemical sterilization, to ensure it remains free of contaminants between uses. Always follow the instructions provided by Medimaging Integrated Solution, Inc. for proper handling and reprocessing.
What are the key differences between the MiiS Horus Endoscope Display System - Tablet and the Video Box?
The MiiS Horus Endoscope Display System offers two display options: a Tablet and a Video Box. The Tablet provides a portable, handheld display for real-time imaging, ideal for clinicians who need mobility during procedures. The Video Box, on the other hand, is a stationary unit designed for high-resolution streaming and display in fixed clinical environments like endoscopy suites or operating rooms. Both systems are non-sterile, single-use accessories and are MRI-safe, ensuring compatibility with magnetic resonance imaging environments.
Can the MiiS Horus Bronchoscope be used in MRI environments, and how does this affect its display systems?
The MiiS Horus Bronchoscope itself is not explicitly stated as MRI-safe in the provided data, but the accompanying Endoscope Display Systems (Tablet and Video Box) are explicitly designed for MRI-safe operation. This means the display systems can be used in magnetic resonance imaging environments without interference, though the bronchoscope’s compatibility with MRI would need to be verified separately based on its materials and construction. Always confirm with the manufacturer if MRI compatibility is a critical requirement for your workflow.
What regulatory pathways have the MiiS Horus Bronchoscope and its display systems undergone, and which advisory committee was involved?
The MiiS Horus Bronchoscope and its display systems have undergone FDA 510(k) clearance under the Ear, Nose, and Throat (EN) advisory committee, with a decision described as *Substantially Equivalent*. Additionally, they comply with the EU Medical Device Regulation (MDR), ensuring they meet both U.S. and European regulatory standards. The clearance was filed under product code EOQ and received on May 1, 2024, following a review by the EN committee.
Are there multiple sizes or models of the MiiS Horus Bronchoscope, and if so, how do they differ?
The provided data does not specify distinct sizes or models of the MiiS Horus Bronchoscope beyond its designation as a *flexible endoscope* for respiratory and upper gastrointestinal tract visualization. However, flexible bronchoscopes typically come in varying lengths and diameters (e.g., pediatric vs. adult sizes) to accommodate different patient anatomies and procedural needs. For exact specifications, such as shaft length or channel diameter, you would need to consult the manufacturer’s product documentation or contact Medimaging Integrated Solution, Inc. directly.
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: Medimaging Integrated Solution Inc. - MiiS, List of official Miis - MiiWiki, Medimaging Integrated Solution Inc. - miis.com.tw, Horus Endoscope │ MiiS - YouTube
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 | K234113 | Class II | Active |
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Manufacturer
- Manufacturer
- Medimaging Integrated Solution, Inc (Miis)
Sources (3)
- FDA 510(k) K234113 24 fields · synced Sep 20, 2026
- EUDAMED 6959039a-6eeb-4b12-a0a1-01d2480d5153 61 fields · synced Jul 9, 2026
- EUDAMED 17cc8460-4188-4b83-8b2a-861712d9d5ea 61 fields · synced Jul 11, 2026