RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review— 510(k) K170750
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K170750 for RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review, Substantially Equivalent on 2017-08-24. 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
- Traditional
- Location
- Munich, DE
Recent devices under product code MUJ
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view allRecalls naming K170750
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170750.
Data sourced from openFDA. This site is unofficial and independent of the FDA.