RT Elements (4.5) +11 more— 510(k) K250440
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K250440 for RT Elements (4.5) +11 more, Substantially Equivalent on 2025-06-17. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Device name as filed
- 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
- Applicant
- Brainlab AG
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Recent devices under product code MUJ
view allMore clearances from Brainlab AG
view all- K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- K252562 — Spine & Trauma Navigation Instruments
- K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
- K243142 — Cranial 4Pi Immobilization
- K243633 — Brainlab Elements (7.0) +5 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.