# K030534: Variseed 7.1

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: May 21, 2003 after 90 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- 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: 2 generations back to K924240 (1993). 4 ancestors in all.
83 later devices descend from it; 3 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982821: MMS Therpacplus B3DTUI Model Number 6.7, Multimedia Medical Systems, Inc. (1998) Summary page 2.
- K992762: Brachyvision 6.0, Varian Assoc., Inc. (2000) Summary page 1.

## Most influential descendants
- K103576: Mim 5.2 (Brachy) (2011), 79 descendants of its own
- K151913: MIM-Thin Client (mobile) (2016), 68 descendants of its own
- K172218: MIM – Y90 Dosimetry (2017), 67 descendants of its own
- K180815: MIM - SPECTRA Quant (2018), 54 descendants of its own
- K182624: MIM - MRT Dosimetry (2018), 53 descendants of its own

## Recalls of this device
- Jan 25, 2012 · Not classified · Z-1385-2012: Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment.

## Indications for use
VariSeed 7.1 is a software application for planning and evaluating brachytherapy procedures for the treatment of prostate cancer that can be modeled according to AAPM TG-43. It facilitates pre-operative planning and post-operative evaluation as well as intra-operative planning and evaluation.

Source page: https://510kreport.com/device/K030534
Methodology: https://510kreport.com/methodology