# K040773: Pelvis Bellyboard Plus Patient Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Bionix Development Corp.
- Decided: Apr 9, 2004 after 14 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 K895697 (1990). 7 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023293: Med-Tec Bellyboard, Models MT-Bba-01 & MT-Bba-02, Med-Tec,Inc. (2002) Summary page 1.
- K935300: Vac-Lok Immobilization System, Medtec, Inc. (1994) Summary page 5.
- K895697: Vac Fix (R) System, S&S Par Scientific (1990) Summary page 5.
- K951808: Med-Tec Redi-Foam, Medtec, Inc. (1995) Summary page 8.
- K952457: Rapid-Foam, The Soule Co., Inc. (1995) Summary page 8.
- K973842: Carbon Fiber Conformal Couch Top, Medtec, Inc. (1997) Summary page 11.
- K935412: Med-Tec, Inc. Breast Board, MT-200, Medtec, Inc. (1994) Summary page 13.
- (no number) AccuFix IMRT Quick-fix Carbon Fiber Pelvis System: named in the summary without a submission number

## Most influential descendants
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (2016), 3 descendants of its own
- K210894: Siddharth-II; Impact (2021), 1 descendant of its own
- K132124: Klarity Vacuum Bag, Klarity Mold Cushion (2013), 1 descendant of its own
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own

## Indications for use
The Bionix Pelvis BellyBoard PLUS patient positioning system developed and manufactured by Bionix Development Corp., 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. The Bionix SecureVac patient positioning system developed and manufactured by Bionix Development Corp., 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. The Bionix SecureFoam patient positioning system developed and manufactured by Bionix Development Corp., 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. The Bionix SecureFit Bar patient positioning device developed and manufactured by Bionix Development Corp., 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. The Bionix Extended Butterfly Armboard patient positioning device, developed and manufactured by Bionix Development Corp., 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/K040773
Methodology: https://510kreport.com/methodology