# K042864: Implant Sciences Corp, Model HDR-4140

- Pathway: 510(k) (Traditional)
- Applicant: Implant Sciences Corp.
- Decided: Jan 6, 2005 after 80 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 K864210 (1986). 6 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030745: Gammamed 212 and 232 Source Assembly, Varian Medical Systems (2003) Summary page 1.
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 1.
- K991571: 10 Curie Irdium 192, CSN00100-192, Alpha-Omega Services, Inc. (2000) Summary page 1.

## Most influential descendants
- K090366: Spec Model M-31 (2009), 1 descendant of its own
- K161396: SPEC Model M23 (2016), 0 descendants of its own
- K141038: Ant Model 1 (2014), 0 descendants of its own
- K070468: Implant Sciences Corp. Model HDR 4454 (2007), 0 descendants of its own

## Indications for use
Implant Sciences Model HDR 4140 Source Assembly, with individual activity up to 27Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, hyperthermia or chemotherapy.

Source page: https://510kreport.com/device/K042864
Methodology: https://510kreport.com/methodology