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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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