# K180027: ACCUSYTE 3D Fiducial Marker

- Pathway: 510(k) (Traditional)
- Applicant: Radiation Products, LLC
- Decided: Jul 18, 2018 after 196 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001807 (2001). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071614: Fiducial Markers, Civco (2007) Summary page 4.
- K143484: BioZorb Marker, Focal Therapeutics (2015) Summary page 4.
- K130735: Synthetic Absorbable Suture, Foosin Medical Supplies Inc., Ltd. (2014) Summary page 4.

## Indications for use
The ACCUSYTE™ 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed. In addition, the Markers are indicated on situations where soft tissue needs to be marked for future medical procedure such as subsequent Radiation Therapy.

Source page: https://510kreport.com/device/K180027
Methodology: https://510kreport.com/methodology