# K011763: Omnidos

- Pathway: 510(k) (Traditional)
- Applicant: Scanditronix Medical AB
- Decided: Sep 5, 2001 after 90 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: 2 generations back to K934303 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945321: Wellhofer WP700 V. 3.2, Medical Physics Instrumentation, Inc. (1995) Summary page 1.
- K934303: RFA A-300, Scanditronix, Inc. (1994) Summary page 1.
- K961400: Rfa-300, Lda Utility, Scanditronix Medical AB (1997) Summary page 1.

## Most influential descendants
- K092018: Omnipro Incline (2009), 0 descendants of its own

## Indications for use
OmniDos is a system software utilising hardware components to measure radiation dose distribution. The hardware consists of water phantoms, air scanners, film scanners/ digitizers and single or array detectors. The hardware comes from Scanditronix Medical, the sister company Wellhofer Dosimetry and from 3rd party vendors. OmniDos is used to accurately analyse and handle the measured dose distribution in quality assurance purposes, for calibration of radiation devices, as input data to Treatment Planning Systems, for acceptance testing, beam tuning and in research.

Source page: https://510kreport.com/device/K011763
Methodology: https://510kreport.com/methodology