# K031634: Omnipro I'mrt

- Pathway: 510(k) (Traditional)
- Applicant: Wellhofer Dosimetrie
- Decided: Aug 29, 2003 after 94 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 K935928 (1994). 1 ancestor in all.
34 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935928: Rit 113 Film Analysis System, Radiological Imaging Technology, Inc. (1994) Summary page 1.

## Most influential descendants
- K072374: Compass (2007), 31 descendants of its own
- K140660: MOBIUS3D (2014), 23 descendants of its own
- K153014: Mobius3D (2016), 13 descendants of its own
- K191761: Mobius3D (2019), 5 descendants of its own
- K141800: Perfraction (2014), 5 descendants of its own

## Indications for use
The intended use of the OmniPro I'mRT system is to: verify the treatment plan and delivered dose of intensity modulated or static beams prior to treatment verify the intensity maps during IMRT delivery prior to treatment verify the absolute dose in given points for IMRT fields.

Source page: https://510kreport.com/device/K031634
Methodology: https://510kreport.com/methodology