RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
FDA 510(k) clearance K190664 · decided 2019-04-12
Clearance details
- K-number
- K190664
- Device name
- RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
- Applicant
- Brainlab AG
- Decision
- Substantially Equivalent
- Date received
- 2019-03-15
- Decision date
- 2019-04-12
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Munich, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.