Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Elekta Radiosurgery with 1 510(k) clearance. The most recent is a 510(k) clearance dated Nov 20, 1995: LEKSELL GAMMA UNIT MODEL 23004,TYPE B..
| Date | Record | Source |
|---|---|---|
| Nov 20, 1995 | LEKSELL GAMMA UNIT MODEL 23004,TYPE B.K924849 ยท IWB | 510(k) clearances |
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
