# K122888: CDR Systems Precision Patient Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Cdr Systems, Inc.
- Decided: Apr 30, 2013 after 222 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: 5 generations back to K935300 (1994). 33 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100691: Omni V SBRT Positioning System, Model RT-4500, Bionix Development Corp. (2010) Summary page 1.
- K050701: Thigh and Foot Positioner, Suprone Plus, Model RT-6010, Bionix Development Corp. (2005) Summary page 1.
- K040773: Pelvis Bellyboard Plus Patient Positioning System, Bionix Development Corp. (2004) Summary page 1.
- K030051: Versaboard, Model 7040, Bionix Development Corp. (2003) Summary page 1.
- K111340: Head and Neck Immobilization System, Body Immobilization System, Medtec, Inc. (2011) Summary page 1.

## Most influential descendants
- 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
- K171133: Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories (2017), 0 descendants of its own

## Indications for use
CDR Systems Precision Patient Positioning System is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments. Place a clean sheet over the device to ensure a clean device from patient to patient.

Source page: https://510kreport.com/device/K122888
Methodology: https://510kreport.com/methodology