Medical Device Manufacturer · SE , Stockholm

Elekta Solutions AB

14 submissions · 14 cleared · Since 2020
14
Total
14
Cleared
0
Denied

Elekta Solutions AB — FDA 510(k) Submissions

Elekta Solutions AB has submitted 14 FDA 510(k) premarket notifications since 2020, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Accelerator, Linear, Medical, System, Planning, Radiation Therapy Treatment, System, Radiation Therapy, Radionuclide, Radiological Image Processing Software For Radiation Therapy, System, Image Processing, Radiological . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
Monaco RTP System (6.3)
K252002 · MUJ System, Planning,... · Radiology
Feb 2026 237d
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
K252188 · IYE Accelerator, Linear, Medical · Radiology
Jan 2026 185d
ProKnow DS
K251363 · LLZ System, Image Processing,... · Radiology
Oct 2025 160d
Leksell Gamma Knife? (Elekta Esprit); Leksell Gamma Knife? (Icon?); Leksell Gamma Knife? (Perfexion?)
K250391 · IWB System, Radiation... · Radiology
Jul 2025 140d
Leksell GammaPlan (LGP)
K232854 · IWB System, Radiation... · Radiology
Feb 2024 146d
Elekta Unity
K223209 · IYE Accelerator, Linear, Medical · Radiology
Feb 2023 129d
MOSAIQ? OIS (Oncology Information System)
K223229 · IYE Accelerator, Linear, Medical · Radiology
Feb 2023 128d
Monaco RTP System
K223233 · MUJ System, Planning,... · Radiology
Feb 2023 127d
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
K222047 · IWB System, Radiation... · Radiology
Oct 2022 106d
Monaco RTP System
K213787 · MUJ System, Planning,... · Radiology
May 2022 162d
Advanced Algorithms for Treatment Management Applications (AATMA)
K212218 · QKB Radiological Image... · Radiology
Oct 2021 101d
Elekta Unity
K212114 · IYE Accelerator, Linear, Medical · Radiology
Oct 2021 86d
Monaco Rtp System
K202789 · MUJ System, Planning,... · Radiology
Feb 2021 154d
MOSAIQ Oncology Information System
K203172 · IYE Accelerator, Linear, Medical · Radiology
Dec 2020 53d
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