# K190894: TOTIM Patient Cushion Immobilization System

- Pathway: 510(k) (Traditional)
- Applicant: Essebi Medical Srl
- Decided: Apr 30, 2019 after 25 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 K951808 (1995). 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)
- K951808: Med-Tec Redi-Foam, Medtec, Inc. (1995) Summary page 4.

## Indications for use
The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the body, head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), Magnetic Resonance (MR) Imaging, to support treatment planning.

Source page: https://510kreport.com/device/K190894
Methodology: https://510kreport.com/methodology