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Elekta Solutions AB

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

器械总数15
类别0
最新FDA决定
类型编号器械名称代码日期操作
510(k) K261932 莱克塞尔® Vantage 立体定向系统HAW2026-08-05 查看
510(k) K252002 Monaco RTP系统（6.3）MUJ2026-02-19 查看
510(k) K252188 EMLA (Elekta Evo)；EMLA (VersaHD)；EMLA (Elekta Harmony Pro)；EMLA (Elekta Infintiy)；EMLA (Elekta Harmony)；EMLA (Elekta Synergy)IYE2026-01-15 查看
510(k) K251363 ProKnow DSLLZ2025-10-08 查看
510(k) K250391 Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon®); Leksell Gamma Knife® (Perfexion®)IWB2025-07-02 查看
510(k) K232854 Leksell GammaPlan (LGP)IWB2024-02-08 查看
510(k) K223209 Elekta UnityIYE2023-02-23 查看
510(k) K223233 Monaco RTP系统MUJ2023-02-23 查看
510(k) K223229 MOSAIQ® OIS（肿瘤学信息系统）IYE2023-02-23 查看
510(k) K222047 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (新型号变体)IWB2022-10-26 查看
510(k) K213787 Monaco RTP系统MUJ2022-05-17 查看
510(k) K212218 高级治疗管理应用算法（AATMA）QKB2021-10-25 查看
510(k) K212114 Elekta UnityIYE2021-10-01 查看
510(k) K202789 Monaco Rtp系统MUJ2021-02-23 查看
510(k) K203172 MOSAIQ肿瘤学信息系统IYE2020-12-18 查看
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