Medical Device Manufacturer · SE , Stockholm

Elekta Solutions AB - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2020

Recent clearances: Leksell® Vantage Stereotactic System, Monaco RTP System (6.3), EMLA (Elekta Evo)

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Elekta Solutions AB Radiology ✕

14 devices

1-12 of 14

Cleared Feb 19, 2026

Monaco RTP System (6.3)

Radiology · 237d

Cleared Jan 15, 2026

EMLA (Elekta Evo)

Radiology · 185d

Cleared Oct 08, 2025

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

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

Radiology · 86d