# K102811: Aos Orion IR-192 Source Cable

- Pathway: 510(k) (Traditional)
- Applicant: Alpha-Omega Services, Inc.
- Decided: Jun 2, 2011 after 247 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: 5 generations back to K864210 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092804: Microselectron HDR V2, Model 105.999, Nucletron Corp. (2009) Summary page 1.
- K061354: Microselectron V3, Model 106.990, Nucletron Corporation (2006) Summary page 1.

## Indications for use
The AOS Orion Ir-192 Source Cable is a sealed 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. This device is the replaceable Ir-192 source for the Nucletron Corp. MicroSelectron HDR V2 and V3 Afterloaders.

Source page: https://510kreport.com/device/K102811
Methodology: https://510kreport.com/methodology