RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review— 510(k) K190664
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K190664 for RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review, Substantially Equivalent on 2019-04-12. Applicant: Brainlab AG. Device class: 2.
Clearance details
- 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
- Special
- Location
- Munich, DE
Recent devices under product code MUJ
view allMore clearances from Brainlab AG
view allData sourced from openFDA. This site is unofficial and independent of the FDA.