Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
FDA 510(k) K252476 · Brainlab AG
510(k) numberK252476
Submission
- Device name
- Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- Applicant
- Brainlab AG
Munich, DE - Received
- August 7, 2025
- Decision date
- October 16, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout cleared by the FDA?
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (K252476) received a 510(k) decision of Substantially Equivalent on October 16, 2025, 70 days after the submission was received.
What is the product code of K252476?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.