# K991571: 10 Curie Irdium 192, CSN00100-192

- Pathway: 510(k) (Traditional)
- Applicant: Alpha-Omega Services, Inc.
- Decided: Feb 22, 2000 after 293 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: 1 generation back to K864210 (1986). 1 ancestor in all.
11 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864210: Microselectron-HDR (High Dose Rate), Nucletron-Oldelft Corp. (1986) Summary page 1.

## Most influential descendants
- K042864: Implant Sciences Corp, Model HDR-4140 (2005), 4 descendants of its own
- K132969: Spec Model M15 (2014), 3 descendants of its own
- K090366: Spec Model M-31 (2009), 1 descendant of its own
- K052947: Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy Source (2006), 1 descendant of its own
- K162573: Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source (2016), 0 descendants of its own

## Indications for use
A high specific activity radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. Device is the active source for a Nucletron Microselection Device.

Source page: https://510kreport.com/device/K991571
Methodology: https://510kreport.com/methodology