# K040687: Onedose Patient Dosimetry System

- Pathway: 510(k) (Traditional)
- Applicant: Sicel Technologies, Inc.
- Decided: Jun 25, 2004 after 101 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 K011332 (2001). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010472: Patient Dose Verification System, Model TN-RD-50, Thomson & Nielsen Electronics, Ltd. (2001) Summary page 2.
- K032725: Mosfet Autosense Wireless, Thomson & Nielsen Electronics, Ltd. (2003) Summary page 2.
- K021463: Model 1133 Ivd PC Version, Sun Nuclear Corp. (2002) Summary page 2.
- K011332: RF-Ivd Wireless Dosimeter-Model 1133, Sun Nuclear Corp. (2001) Summary page 2.

## Most influential descendants
- K052118: Dose Verification System (2006), 8 descendants of its own
- K061051: Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool, DVS-D-a, DVS Dosimeter (2006), 7 descendants of its own
- K071399: Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS Insertion Tool, DVS-D-a: DVS Dosimeter, DVS-R-100 (2007), 6 descendants of its own
- K080004: Dose Verification System Patient Dosimetry System (2008), 5 descendants of its own
- K083035: Dose Verification System Patient Dosimetry System (2008), 4 descendants of its own

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

Source page: https://510kreport.com/device/K040687
Methodology: https://510kreport.com/methodology