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.. FDA records under 7 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Elekta and its 13 subsidiaries with 182 510(k) clearances, 133 device recalls and 3 AI-enabled devices. The most recent is an AI-enabled device dated Feb 19, 2026: Monaco RTP System (6.3).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Elekta and its 13 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 19, 2026 | Monaco RTP System (6.3)K252002 · Radiology | AI-enabled devices |
| Jan 15, 2026 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)K252188 · Radiology | AI-enabled devices |
| Oct 25, 2021 | Advanced Algorithms for Treatment Management Applications (AATMA)K212218 · Radiology | AI-enabled devices |
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
