# K992762: Brachyvision 6.0

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Mar 9, 2000 after 205 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
189 later devices descend from it; 7 cite it directly.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Nucletron Plato Brachytherapy: named in the summary without a submission number

## Most influential descendants
- K050296: Eclipse Treatment Planning System (2005), 101 descendants of its own
- K071873: Modification to Eclipse Treatment Planning System (2007), 94 descendants of its own
- K073020: Eclipse Treatment Planning System (2007), 92 descendants of its own
- K091492: Modification to Eclipse Treatment Planning System (2009), 87 descendants of its own
- K030534: Variseed 7.1 (2003), 83 descendants of its own

## Recalls of this device
- Oct 31, 2003 · Not classified · Z-0176-03: The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.

## Indications for use
BrachyVison 6.0 may be used for any brachytherapy planning activity, but has been specifically optimized for use with remote afterloaders (especially the VariSource unit from Varian), and for use with 3D images such as may be obtained from CT or MRI, or Ultrasound images.

Source page: https://510kreport.com/device/K992762
Methodology: https://510kreport.com/methodology