510(k) clearance
RT Elements (4.6)
- 510(k) number
- K261655
- Applicant
- Brainlab SE
- Decision date
- Oct 5, 2026
- Date received
- May 19, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MUJ
- Device type
- System, Planning, Radiation Therapy Treatment
- Device class
- Class II
- Regulation
- 21 CFR 892.5050
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Munich, DE