RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review— 510(k) K203681

Substantially Equivalent

Brainlab AG

FDA 510(k) clearance K203681 for RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review, Substantially Equivalent on 2021-04-09. 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
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