# K030051: Versaboard, Model 7040

- Pathway: 510(k) (Traditional)
- Applicant: Bionix Development Corp.
- Decided: Apr 4, 2003 after 88 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: 1 generation back to K905007 (1991). 3 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933227: Uni-Frame Head Immobilization System, Medtec, Inc. (1994) Summary page 1.
- K974703: Carbon Fiber Breast Board, Medtec, Inc. (1998) Summary page 3.
- K905007: Standard Breast Boards;  Deluxe Breast Board, Bionix Development Corp. (1991) Summary page 3.

## Most influential descendants
- K060737: Sinmed Positioning Devices (2006), 17 descendants of its own
- K093738: Mri Patient Positioning Devices (2010), 14 descendants of its own
- K111340: Head and Neck Immobilization System, Body Immobilization System (2011), 13 descendants of its own
- K142420: Patient Positioning Devices (2015), 7 descendants of its own
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own

## Indications for use
The VersaBoard patient positioning system developed and manufactured by Bionix Development Corporation, Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

Source page: https://510kreport.com/device/K030051
Methodology: https://510kreport.com/methodology