Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD— 510(k) K210500

Substantially Equivalent

Elekta Limited

FDA 510(k) clearance K210500 for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD, Substantially Equivalent on 2021-06-11. Applicant: Elekta Limited.

Clearance details

Applicant: Elekta Limited
Product code: Code IYE
Advisory panel: Radiology
Date received: 2021-02-22
Decision date: 2021-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crawley, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.