# K191158: The AIO Solution

- Pathway: 510(k) (Traditional)
- Applicant: Orfit Industries NV
- Decided: Aug 6, 2019 after 97 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K210894: Siddharth-II; Impact (2021), 1 descendant of its own
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own
- K202068: The AIO Solution 3.0 (2020), 0 descendants of its own

## Indications for use
The AIO Breast and Lung Board Solution is a positioning and immobilization system to set-up and reproduce the supine position of a breast or lung patient during radiation. The AIO Head and Neck Solution is indicated to aid in supporting the knees or ankles of patients undergoing radiation therapy in the supine or prone position. The device is also used during image acquisition to support treatment planning.

Source page: https://510kreport.com/device/K191158
Methodology: https://510kreport.com/methodology