Medical Device Manufacturer · SE , Stockholm

Elekta Solutions AB - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2020

Total

Cleared

Denied

Elekta Solutions AB has 14 FDA 510(k) cleared radiology devices. Based in Stockholm, SE.

Latest FDA clearance: Feb 2026. Active since 2020.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Elekta Solutions AB

14 devices

1-12 of 14

Cleared Feb 19, 2026

Monaco RTP System (6.3)

Leksell Gamma Knife® (Elekta Esprit)

K250391 · IWB

Radiology · 140d

Cleared Feb 08, 2024

Leksell GammaPlan (LGP)

MOSAIQ® OIS (Oncology Information System)

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife...

Advanced Algorithms for Treatment Management Applications (AATMA)

Elekta Solutions AB - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by Elekta Solutions AB

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