# K171133: Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Qfix
- Decided: Jul 11, 2017 after 85 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: 7 generations back to K935300 (1994). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement, Medtec, Inc. D/B/A Civco Medical Solutions (2016) Summary page 6.

## Indications for use
Device-Specific Intended Use: The Qfix® Abdominal/Thoracic Motion Control System is intended to apply abdominal compression for managing internal body motion during respiration while maintaining maximum comfort to the patient. The Qfix® Abdominal/Thoracic Motion Control System is also intended to promote shallow breathing in radiation therapy or radiology. System Intended Use: The Qfix® Abdominal/Thoracic Motion Control System can be used as part of the Qfix® SBRT Solution and Accessories including, Qfix’s kVue™, Stradivarius™, VacQFix™ and DoseMax™ inserts, overlays, and standalone devices which are intended to immobilize, position and reposition patients undergoing radiation therapy including SBRT.

Source page: https://510kreport.com/device/K171133
Methodology: https://510kreport.com/methodology