Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled 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 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Elekta Oncology Systems with 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 23, 2003: ELEKTA SYNERGY SYSTEM.
| Oct 23, 2003 | ELEKTA SYNERGY SYSTEMK032996 · IYE | 510(k) clearances |
| Aug 14, 2001 | MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)K012289 · IYE | 510(k) clearances |
| Nov 2, 1998 | RT DESKTOPK982713 · IYE | 510(k) clearances |
| Aug 7, 1998 | IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEWK981790 · IYE | 510(k) clearances |
| Dec 17, 1997 | ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONSK973540 · IYE | 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