# K071467: Varisource IX HDR Afterloader

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jul 16, 2007 after 48 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945383 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061582: Varisource 200 HDR Afterloader, Varian Medical Systems, Inc. (2006) Summary page 1.

## Most influential descendants
- K122236: Varisourse IX Brahytherapy Afterloader Varisource IX (T) Brachytherapy Afterloader (2012), 0 descendants of its own

## Recalls of this device
- Jan 5, 2012 · Not classified · Z-1200-2012: Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
- Jan 5, 2012 · Not classified · Z-1199-2012: Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
- Mar 1, 2010 · Not classified · Z-0325-2012: VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment.

## Indications for use
The VariSource iX is indicated, in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled high dose-rate Brachytherapy for conditions anywhere in the body when brachytherapy treatment is indicated.

Source page: https://510kreport.com/device/K071467
Methodology: https://510kreport.com/methodology