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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 10 Results
ProductCode: MUJ Applicant: BRAINLAB AG Decision Date To: 05/24/2024
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rt elements (4.0) Brainlab AG K223279 03/14/2023
rt elements, cranial srs w/ cones, multiple brain mets srs, cranial srs, spine srs, rt qa, dose review Brainlab AG K203681 04/09/2021
rt elements, cranial srs, spine srs, multiple brain mets srs, rt qa, adaptive hybrid surgery analysis, dose review Brainlab AG K190664 04/12/2019
rt elements, cranial srs, spine srs, multiple brain mets srs, rt qa, adaptive hybrid surgery analysis, dose review Brainlab AG K170750 08/24/2017
rt elements, dose review, brain metastases, adaptive hybrid surgery analysis BRAINLAB AG K142108 12/16/2014
modeification to iplan rt dose BRAINLAB AG K080888 06/11/2008
iplan rt dose BRAINLAB AG K053584 07/12/2006
iplan rt fibertracking BRAINLAB AG K052220 09/30/2005
novalis (shaped beam surgery system) BRAINLAB AG K002509 11/03/2000
brainscan BRAINLAB AG K994413 07/13/2000
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