Interlocked Circular Small Field Collimators, Elekta Integrated— 510(k) K161984

Substantially Equivalent

Aktina Medical Corporation

FDA 510(k) clearance K161984 for Interlocked Circular Small Field Collimators, Elekta Integrated, Substantially Equivalent on 2016-09-27. Applicant: Aktina Medical Corporation.

Clearance details

Applicant: Aktina Medical Corporation
Product code: Code IYE
Advisory panel: Radiology
Date received: 2016-07-19
Decision date: 2016-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Congers, NY, US

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.