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

Elekta Solutions AB has 15 FDA 510(k) cleared radiology devices. Based in Stockholm, SE.

Latest FDA clearance: Aug 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.

510(k) submissions have been managed by Elekta, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - Elekta Solutions AB

15 devices
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