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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K250440
Device Name RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
Applicant
Brainlab AG
Olof-Palme-Str 9
Munich,  DE 81829
Applicant Contact Sadwini Suresh
Correspondent
Brainlab AG
Olof-Palme-Str 9
Munich,  DE 81829
Correspondent Contact Sadwini Suresh
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
QIH  
Date Received02/14/2025
Decision Date 06/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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