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Elekta Solutions AB

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories6
Latest FDA decision2026-08-05
TypeNumberDevice NameCodeDateActions
510(k) K261932 Leksell® Vantage Stereotactic SystemHAW2026-08-05 View
510(k) K252002 Monaco RTP System (6.3)MUJ2026-02-19 View
510(k) K252188 EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)IYE2026-01-15 View
510(k) K251363 ProKnow DSLLZ2025-10-08 View
510(k) K250391 Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)IWB2025-07-02 View
510(k) K232854 Leksell GammaPlan (LGP)IWB2024-02-08 View
510(k) K223233 Monaco RTP SystemMUJ2023-02-23 View
510(k) K223209 Elekta UnityIYE2023-02-23 View
510(k) K223229 MOSAIQ® OIS (Oncology Information System)IYE2023-02-23 View
510(k) K222047 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)IWB2022-10-26 View
510(k) K213787 Monaco RTP SystemMUJ2022-05-17 View
510(k) K212218 Advanced Algorithms for Treatment Management Applications (AATMA)QKB2021-10-25 View
510(k) K212114 Elekta UnityIYE2021-10-01 View
510(k) K202789 Monaco Rtp SystemMUJ2021-02-23 View
510(k) K203172 MOSAIQ Oncology Information SystemIYE2020-12-18 View
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