AGILITY— 510(k) K123808

Substantially Equivalent

Elekta , Ltd.

FDA 510(k) clearance K123808 for AGILITY, Substantially Equivalent on 2013-04-04. Applicant: Elekta , Ltd..

Clearance details

Applicant: Elekta , Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2012-12-11
Decision date: 2013-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crawley, West Sussex, 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.