CygneX I System— 510(k) K143560

Substantially Equivalent

Accuthera, Inc.

FDA 510(k) clearance K143560 for CygneX I System, Substantially Equivalent on 2015-10-05. Applicant: Accuthera, Inc..

Clearance details

Applicant: Accuthera, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2014-12-16
Decision date: 2015-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kawasaki, JP

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.