Elekta Unity— 510(k) K192482

Substantially Equivalent

Elekta Limited

FDA 510(k) clearance K192482 for Elekta Unity, Substantially Equivalent on 2019-12-05. Applicant: Elekta Limited.

Clearance details

Applicant: Elekta Limited
Product code: Code IYE
Advisory panel: Radiology
Date received: 2019-09-10
Decision date: 2019-12-05
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.