# K061582: Varisource 200 HDR Afterloader

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jul 25, 2006 after 48 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- 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 K945383 (1995). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945383: High Dose Rate Afterloader, Varian Assoc., Inc. (1995) Summary page 3.

## Most influential descendants
- K072683: Axxent Electronic Brachytherapy System (2008), 5 descendants of its own
- K122951: Xoft Axxent Electronic Brachytherapy System Model 110 (2013), 4 descendants of its own
- K153570: Axxent Electronic Brachytherapy System Model 110 XP 1200 (2016), 1 descendant of its own
- K132092: Esteya (2013), 1 descendant of its own
- K071467: Varisource IX HDR Afterloader (2007), 1 descendant of its own

## Indications for use
The VariSource 200 System is a High Dose Rate Brachytherapy Afterloader used to treat lesions, tumors and conditions in the body where radiation is indicated.

Source page: https://510kreport.com/device/K061582
Methodology: https://510kreport.com/methodology