Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of ElektaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Elekta Solutions with 15 510(k) clearances, 3 AI-enabled devices and 2 device recalls. The most recent is a 510(k) clearance dated Aug 5, 2026: Leksell® Vantage Stereotactic System.
510(k) clearances: 15
AI-enabled devices: 3
Device recalls: 2
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
02017Records0
020182018Records0vs 2017+0
02019Records0vs 2018+0
120202020Records1vs 2019+1
42021Records4vs 2020+3
220222022Records2vs 2021−2
32023Records3vs 2022+1
120242024Records1vs 2023−2
32025Records3vs 2024+2
320262026 to dateRecords3
Latest Records
Newest first across sources; each opens the record
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata.How this page is built
