# K151207: Proton Immobilization Solution

- Pathway: 510(k) (Traditional)
- Applicant: Orfit Industries NV
- Decided: Jul 28, 2015 after 83 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K171734: HP PRO Positioning Device (2017), 0 descendants of its own

## Indications for use
The Proton IMMOBILIZATION Solution is indicated to assist in the proper positioning and repositioning of patients for radiation therapy and radiosurgery and treatment including electron, photon, and proton treatments.

Source page: https://510kreport.com/device/K151207
Methodology: https://510kreport.com/methodology