RT Elements (4.6)— 510(k) K261655
Substantially EquivalentBrainlab SE
FDA 510(k) clearance K261655 for RT Elements (4.6), Substantially Equivalent on 2026-10-05. Applicant: Brainlab SE. Device class: 2.
Summary
RT Elements version 4.6 from Brainlab is filed under MUJ, radiation therapy treatment planning systems. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 892.5050. The Radiology panel reviewed it as a Traditional 510(k).
Brainlab filed from Munich, Germany. Review took 139 days (May 19 to October 5, 2026).
Clearance details
- Applicant
- Brainlab SE
- Product code
- Product 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
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