# K092018: Omnipro Incline

- Pathway: 510(k) (Traditional)
- Applicant: Iba Dosimetry GmbH
- Decided: Sep 18, 2009 after 74 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: 3 generations back to K934303 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011763: Omnidos, Scanditronix Medical AB (2001) Summary page 1.

## Indications for use
The OmniPro Incline is a QA beam measuring system intended to be used for the verification of dose distribution in radio therapy. The system is intended to measure proton, photon and electron beams.

Source page: https://510kreport.com/device/K092018
Methodology: https://510kreport.com/methodology