Brainlab AG · Class II · Cleared Oct 16, 2025
| K-number | K252476 |
| Device name | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout |
| Applicant | Brainlab AG |
| Product code | LLZ |
| Device class | Class II |
| Decision date | Oct 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
Viewer 5.4 is medical image management and processing software that displays DICOM data from medical imaging devices, including native slices, reconstructions, and volume-rendered views. It supports basic image manipulation (windowing, alignment), measurement tools (distances and angles), and 3D visualization, but is not intended for diagnosis or treatment planning.
The subject device has identical computer hardware requirements to the predicate: DirectX 11 graphics with 512 MB memory, 1280x1024 display resolution, 4 physical cores processor, 4GB RAM (8GB for 3D stereo), and mouse/touchscreen input. It supports Magic Leap 2 medtech and IT version glasses, Windows Server 2012/2016/2019 or minimum Windows 10, and MacOS. It includes updated components: Universal Atlas Performer 6.0, Universal Atlas Transfer Performer 6.0.1, and DICOM Proxy 5.1.1 with bug fixes for patient data merges.
Not stated in this summary. The document references FDA guidance on device software premarket submissions but does not cite specific ISO, IEC, or ASTM consensus standards.
The subject device has identical indications for use, functionality, and hardware specifications as the predicate device (Viewer 5.4; K232759). No major changes exist between them. Performance testing including software verification/validation, ambient light tests, hospital environment compatibility, display quality tests, and measurement accuracy tests (within 1 millimeter deviation) confirm equivalent performance. Based on similar functionality, intended use, and technological characteristics, the device is substantially equivalent to the predicate.
View the full FDA submission: accessdata.fda.gov