Elekta Solutions AB - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
FDA 510(k) cleared devices by Elekta Solutions AB Radiology ✕
14 devices
Cleared
Feb 19, 2026
Monaco RTP System (6.3)
Radiology
237d
Cleared
Jan 15, 2026
EMLA (Elekta Evo)
Radiology
185d
Cleared
Oct 08, 2025
ProKnow DS
Radiology
160d
Cleared
Jul 02, 2025
Leksell Gamma Knife® (Elekta Esprit)
Radiology
140d
Cleared
Feb 08, 2024
Leksell GammaPlan (LGP)
Radiology
146d
Cleared
Feb 23, 2023
Elekta Unity
Radiology
129d
Cleared
Feb 23, 2023
MOSAIQ® OIS (Oncology Information System)
Radiology
128d
Cleared
Feb 23, 2023
Monaco RTP System
Radiology
127d
Cleared
Oct 26, 2022
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife...
Radiology
106d
Cleared
May 17, 2022
Monaco RTP System
Radiology
162d
Cleared
Oct 25, 2021
Advanced Algorithms for Treatment Management Applications (AATMA)
Radiology
101d
Cleared
Oct 01, 2021
Elekta Unity
Radiology
86d
Cleared
Feb 23, 2021
Monaco Rtp System
Radiology
154d
Cleared
Dec 18, 2020
MOSAIQ Oncology Information System
Radiology
53d