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Elekta Solutions AB FDA Approvals
0 new drug approvals and 14 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Leksell® Vantage Stereotactic System510(k)Aug 5, 2026Neurology |
| Monaco RTP System (6.3)510(k)Feb 19, 2026Radiology |
| EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)510(k)Jan 15, 2026Radiology |
| ProKnow DS510(k)Oct 8, 2025Radiology |
| Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion)510(k)Jul 2, 2025Radiology |
| Leksell GammaPlan (LGP)510(k)Feb 8, 2024Radiology |
| Elekta Unity510(k)Feb 23, 2023Radiology |
| MOSAIQ® OIS (Oncology Information System)510(k)Feb 23, 2023Radiology |
| Monaco RTP System510(k)Feb 23, 2023Radiology |
| Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)510(k)Oct 26, 2022Radiology |
| Monaco RTP System510(k)May 17, 2022Radiology |
| Advanced Algorithms for Treatment Management Applications (AATMA)510(k)Oct 25, 2021Radiology |
| Elekta Unity510(k)Oct 1, 2021Radiology |
| Monaco Rtp System510(k)Feb 23, 2021Radiology |