# K162002: Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay

- Pathway: 510(k) (Traditional)
- Applicant: Zdi, Solutions, LLC
- Decided: Nov 1, 2016 after 104 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 K982624 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982624: Moldcare Head & Neck Cushion, Model # MT-Acl-14242, Med-Tec,Inc. (1998) Summary page 4.

## Indications for use
ZDi Z-Tilt is intended for use by trained medical professionals for patient support and immobilization during external beam radiation therapy in clinics and hospitals. The Z-Tilt and accessories provide patient comfort and stability in various positions for radiation treatment. The Z-Tilt and is used in the treatment of cancer under the supervision and administration of licensed doctors and clinical staff.

Source page: https://510kreport.com/device/K162002
Methodology: https://510kreport.com/methodology