# K110971: Tracer Implantation Kit, Index Implantation Kit

- Pathway: 510(k) (Traditional)
- Applicant: Navotek Medical, Ltd.
- Decided: Jan 10, 2012 after 279 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Navotek RealEye System: named in the summary without a submission number
- (no number) Calypso 4D Localization System: named in the summary without a submission number
- (no number) Visicoil soft tissue marker: named in the summary without a submission number

## Indications for use
The Tracer Implantation Kit is indicated for use to radiographically and radioactively mark soft tissue for future therapeutic procedures. The Tracer is indicated for permanent implantation in the prostate. The Tracer is intended to be used in conjunction with the RealEye system as an adjunct in treatment planning and radiation therapy, to align and monitor the patients position relative to the isocenter of a linear acceterator. The IndeX Implantation Kit is indicated for use to radiographically mark soft tissue for future therapeutic procedures. The IndeX is intended to be used as a radiographic fidlucial marker for visualization using x-ray, CT, or Cone Beam CT.

Source page: https://510kreport.com/device/K110971
Methodology: https://510kreport.com/methodology