# K102765: Pronex

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Dec 7, 2010 after 74 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: 2 generations back to K935411 (1994). 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)
- K090349: Clearvue Prone Breast Treatment Table, Orbital Therapy, LLC (2009) Summary page 1.
- K971382: Prone Breast Positioning Board, Model #37-018, Victoreen, Inc. (1997) Summary page 1.

## Indications for use
Pronex is used to position a patient for prone breast radiation therapy.

Source page: https://510kreport.com/device/K102765
Methodology: https://510kreport.com/methodology