# K013660: Genetra

- Pathway: 510(k) (Special)
- Applicant: Radiomed Corporation
- Decided: Dec 5, 2001 after 29 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K874787 (1987). 3 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001070: Radiomed Source, Radiomed Corp. (2000) Summary page 1.

## Most influential descendants
- K022326: Radiomed Marker (2003), 21 descendants of its own
- K031206: Radiomed Soft Tissue Marker (2003), 20 descendants of its own
- K070305: Pre-Loaded Visicoil (2007), 11 descendants of its own
- K080726: Calypso 4D Localization System (2008), 9 descendants of its own
- K102373: Calypso System with Dynamic Edge Gating (2010), 6 descendants of its own

## Indications for use
GENETRA™ with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized tumors. They can be used either as the primary treatment or as treatment for residual disease after excision of primary or recurrent tumors. GENETRA™ may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

Source page: https://510kreport.com/device/K013660
Methodology: https://510kreport.com/methodology