# K150636: VariSeed 9.0

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: May 8, 2015 after 58 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: 3 generations back to K924240 (1993). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030534: Variseed 7.1, Varian Medical Systems (2003) Summary page 4.

## Most influential descendants
- K232400: VariSeed (v10) (2023), 0 descendants of its own

## Indications for use
VariSeed is indicated for use as a treatment planning software application used by medical professionals to plan, guide, optimize and document low-dose-rate brachytherapy procedures and for use as a biopsy procedure tracking software application used by medical professionals to plan, guide, and document biopsy procedures based on template guided needle insertion. VariSeed may be used on any patient considered suitable for this type of treatment and is intended to be used outside of the sterile field in an operating room environment or in a normal office environment.

Source page: https://510kreport.com/device/K150636
Methodology: https://510kreport.com/methodology