# K131428: Radvision

- Pathway: 510(k) (Traditional)
- Applicant: Acoustic Medsystems, Inc.
- Decided: Jul 16, 2013 after 60 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850571 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982696: Interplant, Burdette Medical Systems, Inc. (1999) Summary page 1.
- K992762: Brachyvision 6.0, Varian Assoc., Inc. (2000) Summary page 1.
- K030534: Variseed 7.1, Varian Medical Systems (2003) Summary page 1.

## Indications for use
The intended use of Acoustic MedSystems, Inc. RadVision Dose Planning and Treatment Systems is to provide patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or HOR afterloader devices. In addition to planning and treatment, PadVision also allows volume and dose calculations, 2D and 3D anatomy arnd dose visualizations, and post treatment seed localization. PadVision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using either temporary or permanent implants ot various radioisotopes.

Source page: https://510kreport.com/device/K131428
Methodology: https://510kreport.com/methodology