# K232489: VenusX

- Pathway: 510(k) (Traditional)
- Applicant: Linatech, LLC
- Decided: Apr 12, 2024 after 239 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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: 6 generations back to K913119 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101751: Varian Unique Single Energy Linear Accelerator, Varian Medical Systems, Oncology Systems (2010) Summary page 4.

## Indications for use
The VenusX radiotherapy delivery system is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Source page: https://510kreport.com/device/K232489
Methodology: https://510kreport.com/methodology