Identifiers
- 510(k) Number
- K210072 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HOLOSCOPE-i is a medical holography system designed for advanced image processing and real-time 3D visualization. Classified under the device type 'System, Image Processing, Radiological,' it generates interactive holographic displays to enhance procedural guidance in interventional radiology and diagnostic imaging.
This system is intended for use in clinical environments such as interventional suites, hybrid operating rooms, and diagnostic clinics. Supplied as a reusable device, it requires no specific sterility standards but is regulated under FDA 510(k) clearance (K210072) and EU MDR. The system operates within the LLZ product code category and is not MRI-safe or single-use.
Frequently asked questions
What clinical settings is the HOLOSCOPE-i intended for and how does it enhance procedures in those environments?
The HOLOSCOPE-i is designed for use in interventional suites, hybrid operating rooms, and diagnostic clinics, where it provides real-time 3D holographic visualization to improve procedural guidance during interventional radiology and diagnostic imaging. Its interactive holographic displays help clinicians visualize complex anatomical structures dynamically, reducing reliance on traditional 2D imaging and potentially improving precision and workflow efficiency.
Is the HOLOSCOPE-i a single-use or reusable device, and what does that mean for maintenance and cleaning?
The HOLOSCOPE-i is a reusable device, meaning it is not intended for single-use disposal. Since it is not classified as sterile, it does not require sterilization but must be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and hygiene in clinical environments. Reusability also implies it may require periodic servicing or calibration to maintain performance standards.
How is the HOLOSCOPE-i regulated, and what does its FDA 510(k) clearance (K210072) indicate about its safety and effectiveness?
The HOLOSCOPE-i holds FDA 510(k) clearance under the product code LLZ, classified as a 'System, Image Processing, Radiological.' The clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device in terms of technological characteristics and intended use. This means the FDA has reviewed its design and determined it meets applicable safety and effectiveness requirements for its specified applications in interventional radiology and diagnostic imaging.
What types of environments or rooms should the HOLOSCOPE-i be installed in, and are there any specific compatibility concerns to note?
The HOLOSCOPE-i is intended for installation in clinical environments like interventional suites, hybrid operating rooms, and diagnostic clinics, where advanced imaging and procedural guidance are required. It is not MRI-safe, so it should not be used in or near MRI environments. The system’s design focuses on real-time 3D visualization, so compatibility concerns primarily revolve around ensuring proper electrical grounding, network connectivity, and space requirements for optimal holographic display functionality.
How does the HOLOSCOPE-i differ from traditional 2D imaging systems in terms of its visualization capabilities?
Unlike traditional 2D imaging systems, the HOLOSCOPE-i generates interactive holographic displays that provide real-time 3D visualization. This allows clinicians to manipulate and view anatomical structures from multiple angles without physical movement, enhancing spatial understanding and procedural precision. The system’s holographic output can reduce eye strain and improve depth perception compared to flat-screen 2D displays, particularly useful in complex interventional procedures.
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: RealView Imaging - Medical Holography, Medical Holography - realview, K210072 - HOLOSCOPE-i - Radiology
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 | K210072 | Class II | Active |
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Manufacturer
- Manufacturer
- Real View Imaging , Ltd.
Sources (2)
- FDA 510(k) K210072 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 19, 2026