# K171734: HP PRO Positioning Device

- Pathway: 510(k) (Traditional)
- Applicant: Orfit Industries NV
- Decided: Jul 25, 2017 after 43 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 K151207 (2015). 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)
- K151207: Proton Immobilization Solution, Orfit Industries NV (2015) Summary page 4.

## Indications for use
The HP PRO Positioning Device is indicated to assist in the proper positioning and repositioning of patients for radiation therapy and radiosurgery and treatment with protons.

Source page: https://510kreport.com/device/K171734
Methodology: https://510kreport.com/methodology