Viewer - Mixed Reality Viewer
FDA 510(k)Class II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K232759 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
- Models / Variants
- Viewer (5.4) FDA 510(k)Elements Viewer FDA 510(k)Mixed Reality Viewer FDA 510(k)Smart Layout FDA 510(k)Elements Viewer Smart Layout 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 Elements Viewer Smart Layout (5.4) is a Medical Image Processing System designed for radiology applications. It integrates image review, manipulation, basic measurements, and 3D visualization to enhance diagnostic workflows. The device supports mixed reality overlays and adaptive layout algorithms to optimize display and analysis of medical imaging data. Its primary function is to streamline the assessment of radiological images in clinical settings.
This software-based system is supplied as a standalone application for use in radiology departments and imaging centers. It is intended for single-use sessions per installation, though the underlying software may require periodic updates. The device is classified under Product Code LLZ and has received FDA 510(k) clearance under the Radiology advisory committee. No sterility or reusable components are specified, and MRI safety considerations are not detailed in the provided data.
Frequently asked questions
What is the primary purpose of the Elements Viewer Smart Layout (5.4)?
The Elements Viewer Smart Layout (5.4) is a Medical Image Processing System designed specifically for radiology applications. It integrates image review, manipulation, basic measurements, and 3D visualization to improve diagnostic efficiency. The device also includes mixed reality overlays and adaptive layout algorithms to optimize how medical imaging data is displayed and analyzed, reducing clutter and improving clarity during clinical assessments.
How is the Elements Viewer Smart Layout (5.4) supplied and intended for use?
The Elements Viewer Smart Layout (5.4) is supplied as a standalone software application for installation on radiology department systems or imaging centers. It is intended for single-use sessions per installation, meaning each clinical workflow session operates independently. However, the underlying software may require periodic updates to ensure continued functionality and compatibility with evolving medical imaging standards.
Is the Elements Viewer Smart Layout (5.4) reusable or single-use, and does it require sterilization?
The Elements Viewer Smart Layout (5.4) is a software-based system and is not designed for physical reuse or sterilization. Since it operates as a digital application, its functionality relies on the underlying hardware and software environment where it is installed. No sterility or reusable components are specified for this device, as it is purely a software solution for image processing and visualization.
What regulatory pathway was followed for the FDA clearance of this device?
The Elements Viewer Smart Layout (5.4) received FDA clearance through a 510(k) submission, classified under Product Code LLZ. The device was determined to be substantially equivalent to a legally marketed predicate under the Radiology advisory committee (RA). The clearance was granted on May 21, 2024, following a traditional review process, and the submission was filed by Brainlab AG.
Does this device support mixed reality features, and how does it benefit radiologists?
Yes, the Elements Viewer Smart Layout (5.4) includes mixed reality overlays as a key feature. These overlays allow radiologists to overlay digital annotations, measurements, or 3D reconstructions directly onto medical images, enhancing spatial awareness and diagnostic accuracy. The adaptive layout algorithms further optimize the display by dynamically organizing image windows, reducing screen clutter, and improving workflow efficiency during complex assessments.
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: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout ..., Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout ..., Viewer (5.4); Elements Viewer; Mixed Reality Viewer… - FDA.report, Elements Viewer System (K252476) | Medical Device Navigator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232759 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K232759 24 fields · synced Oct 1, 2026