# K122236: Varisourse IX Brahytherapy Afterloader Varisource IX (T) Brachytherapy Afterloader

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Nov 16, 2012 after 113 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945383 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071467: Varisource IX HDR Afterloader, Varian Medical Systems, Inc. (2007) Summary page 1.

## Recalls of this device
- May 18, 2015 · Class II · Z-1849-2015: After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the sy

## Indications for use
The Variource iX and Variource iX(t) are indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.

Source page: https://510kreport.com/device/K122236
Methodology: https://510kreport.com/methodology