ACCUSYTE 3D Fiducial Marker

FDA 510(k) K180027 · Radiation Products, LLC

Substantially Equivalent

510(k) numberK180027

Submission

Device name
ACCUSYTE 3D Fiducial Marker
Applicant
Radiation Products, LLC
Atlantis, FL, US
Received
January 3, 2018
Decision date
July 18, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

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

ACCUSYTE 3D Fiducial Marker (K180027) received a 510(k) decision of Substantially Equivalent on July 18, 2018, 196 days after the submission was received.

What is the product code of K180027?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.