# K121284: Chabner XRT Garments

- Pathway: 510(k) (Traditional)
- Applicant: Chabner Xrt, LLC
- Decided: Jun 14, 2013 after 410 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 K905007 (1991). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111340: Head and Neck Immobilization System, Body Immobilization System, Medtec, Inc. (2011) Summary page 2.
- K982624: Moldcare Head & Neck Cushion, Model # MT-Acl-14242, Med-Tec,Inc. (1998) Summary page 2.

## Indications for use
Chabner XRT™ Garments are intended to be used as an aid in the support of the patient during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures. The Chabner XRT™ Garments are not intended for pediatric use.

Source page: https://510kreport.com/device/K121284
Methodology: https://510kreport.com/methodology