FDA 510(k) Applications Submitted by Elekta Solutions AB

FDA 510(k) Number Submission Date Device Name Applicant
K213787 12/06/2021 Monaco RTP System Elekta Solutions AB
K222047 07/12/2022 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) Elekta Solutions AB
K202789 09/22/2020 Monaco Rtp System Elekta Solutions AB
K212114 07/07/2021 Elekta Unity Elekta Solutions AB
K212218 07/16/2021 Advanced Algorithms for Treatment Management Applications (AATMA) Elekta Solutions AB
K223209 10/17/2022 Elekta Unity Elekta Solutions AB
K223229 10/18/2022 MOSAIQ« OIS (Oncology Information System) Elekta Solutions AB
K223233 10/19/2022 Monaco RTP System Elekta Solutions AB
K203172 10/26/2020 MOSAIQ Oncology Information System Elekta Solutions AB


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