FDA applicant
Elekta Solutions AB
FDA records 15 decisions for Elekta Solutions AB (Stockholm, SE) from 2020 to 2026: 15 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and MUJ (System, Planning, Radiation Therapy Treatment). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 129 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 6 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Elekta Solutions AB’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Elekta Solutions AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Elekta”
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