FDA 510(k)

ACCUSYTE 3D Fiducial Marker

K-Number: K180027 · 2018-07-18

Decision Date2018-07-18

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ACCUSYTE 3D Fiducial Marker is a medical device manufactured by Radiation Products, LLC. It received FDA 510(k) clearance on 2018-07-18 under approval number K180027. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSYTE 3D Fiducial Marker?

ACCUSYTE 3D Fiducial Marker is a medical device that received FDA 510(k) clearance on 2018-07-18. It is manufactured by Radiation Products, LLC. The 510(k) number is K180027.

When was ACCUSYTE 3D Fiducial Marker approved by the FDA?

ACCUSYTE 3D Fiducial Marker received FDA 510(k) clearance on 2018-07-18, under approval number K180027.

What company makes ACCUSYTE 3D Fiducial Marker?

ACCUSYTE 3D Fiducial Marker is manufactured by Radiation Products, LLC.

What is the FDA product code for ACCUSYTE 3D Fiducial Marker?

The FDA product code for ACCUSYTE 3D Fiducial Marker is IYE.

Related Clinical Trials

NCT05465161 STING MARK Universal Fiducial Marker System RECRUITING

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.