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 the device name listed in this FDA 510(k) record. The listed applicant is Radiation Products, LLC. It received FDA 510(k) clearance on 2018-07-18 under 510(k) 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. The listed applicant is Radiation Products, LLC. The 510(k) number is K180027.

When did ACCUSYTE 3D Fiducial Marker receive FDA 510(k) clearance?

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

Who is the listed applicant for ACCUSYTE 3D Fiducial Marker?

The FDA 510(k) record lists Radiation Products, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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