FDA 510(k) Applications Submitted by Helena Skar
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K190887 | 04/04/2019 | Leksell Vantage Stereotactic System | Elekta Instrument AB |
| K222047 | 07/12/2022 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | Elekta Solutions AB |
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