# K100691: Omni V SBRT Positioning System, Model RT-4500

- Pathway: 510(k) (Traditional)
- Applicant: Bionix Development Corp.
- Decided: May 11, 2010 after 62 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: 4 generations back to K935300 (1994). 10 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K013391: Bodyfix, Medical Intelligence Medizintechnik GmbH (2002) Summary page 1.
- K991336: Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy, Medical Instrumentation & Diagnostics Corp.(Midco) (1999) Summary page 2.

## 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
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own
- K182079: Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask (2018), 0 descendants of its own

## Indications for use
The Omni V SBRT Positioning System developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for stereotactic localization and 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/K100691
Methodology: https://510kreport.com/methodology