K210500

Substantially Equivalent

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

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

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.