ACCUSYTE 3D Fiducial Marker— 510(k) K180027

Substantially Equivalent

Radiation Products, LLC

FDA 510(k) clearance K180027 for ACCUSYTE 3D Fiducial Marker, Substantially Equivalent on 2018-07-18. Applicant: Radiation Products, LLC.

Clearance details

Applicant: Radiation Products, LLC
Product code: Code IYE
Advisory panel: Radiology
Date received: 2018-01-03
Decision date: 2018-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlantis, FL, 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.