Cleared Special

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

K252476 · Brainlab AG · Radiology
Oct 2025
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K252476 is an FDA 510(k) clearance for the Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on October 16, 2025, 70 days after receiving the submission on August 7, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K252476 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2025
Decision Date October 16, 2025
Days to Decision 70 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

More from Brainlab AG

View all
Spine & Trauma Navigation Instruments
K252562 · OLO · Sep 2025
Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
K243432 · OWB · Jul 2025
Cranial 4Pi Immobilization
K243142 · IYE · Jun 2025
RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
K250440 · MUJ · Jun 2025
Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
K243633 · QIH · Jun 2025