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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: LLZ Applicant: BRAINLAB AG Decision Date To: 05/04/2024
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brainlab elements image fusion, contouring (4.5);image fusion (4.5);fibertracking (2.0);bold mri mapping (1.0);image fusion angio (1.0) Brainlab AG K223106 07/14/2023
brainlab elements, brainlab elements contouring, brainlab elements fibertracking, brainlab elements image fusion, brainlab elements image fusion angio Brainlab AG K212420 12/16/2021
elements viewer Brainlab AG K191014 01/23/2020
brainlab elements image fusion angio Brainlab AG K190042 04/25/2019
elements image fusion, elements cranial distortion correction, elements spine curvature correction, elements tram Brainlab AG K170816 09/26/2017
dicom viewer Brainlab AG K153653 04/13/2016
quentry dose review BRAINLAB AG K141199 06/20/2014
iplan (iplan cranial, iplan stereotaxy, iplan ent, iplan cmf, iplan view, iplan spine) BRAINLAB AG K113732 05/07/2012
digital lightbox BRAINLAB AG K093117 12/11/2009
patxfer BRAINLAB AG K021583 08/12/2002
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