# K142668: Lesion-Loc Iodine I-125 Seed/Needle

- Pathway: 510(k) (Traditional)
- Applicant: Intramedical Imaging, LLC
- Decided: Nov 21, 2014 after 63 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 K111979 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122704: Best Localization Needle with I-125 Seed, Best Medical Intl. (2013) Summary page 5.

## Indications for use
Lesion-Loc I-125 Seed/Needle is indicated in the use for localization of lesions (as shown by mammogram or ultrasound) in the breast or other tissue under the direct supervision of a qualified physician. The device is indicated as "single-use sterile device". Lesion-Loc I-125 Seed/needle is not intended for permanant implantation and should be removed in a few days after implantation. It us to be used in conjunction with the Gammaprobe® (IntraMedical Imaging) for localization of lesions (as shown by a mammogram or ultrasound images) in the breast and other tissues.

Source page: https://510kreport.com/device/K142668
Methodology: https://510kreport.com/methodology