# K081859: Modification to Onedose Patient Dosimetry System

- Pathway: 510(k) (Special)
- Applicant: Sicel Technologies, Inc.
- Decided: Aug 4, 2008 after 34 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 K011332 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040687: Onedose Patient Dosimetry System, Sicel Technologies, Inc. (2004) Summary page 1.

## Indications for use
The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy application.

Source page: https://510kreport.com/device/K081859
Methodology: https://510kreport.com/methodology