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Elekta Solutions AB

15 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Leksell® Vantage Stereotactic System (K261932)Elekta Solutions AB2026-08-05
Monaco RTP System (6.3) (K252002)Elekta Solutions AB2026-02-19
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (K252188)Elekta Solutions AB2026-01-15
ProKnow DS (K251363)Elekta Solutions AB2025-10-08
Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) (K250391)Elekta Solutions AB2025-07-02
Leksell GammaPlan (LGP) (K232854)Elekta Solutions AB2024-02-08
Elekta Unity (K223209)Elekta Solutions AB2023-02-23
MOSAIQ® OIS (Oncology Information System) (K223229)Elekta Solutions AB2023-02-23
Monaco RTP System (K223233)Elekta Solutions AB2023-02-23
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (K222047)Elekta Solutions AB2022-10-26
Monaco RTP System (K213787)Elekta Solutions AB2022-05-17
Advanced Algorithms for Treatment Management Applications (AATMA) (K212218)Elekta Solutions AB2021-10-25
Elekta Unity (K212114)Elekta Solutions AB2021-10-01
Monaco Rtp System (K202789)Elekta Solutions AB2021-02-23
MOSAIQ Oncology Information System (K203172)Elekta Solutions AB2020-12-18

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Every clearance here is in the API, with alerts when new ones post.