# K083035: Dose Verification System Patient Dosimetry System

- Pathway: 510(k) (Special)
- Applicant: Sicel Technologies, Inc.
- Decided: Nov 13, 2008 after 30 days
- Product code: NZT (Dosimeter, Ionizing Radiation, Implanted)
- 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: 7 generations back to K011332 (2001). 13 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052118: Dose Verification System, Sicel Technologies, Inc. (2006) Summary page 2.
- K061051: Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool, DVS-D-a, DVS Dosimeter, Sicel Technologies, Inc. (2006) Summary page 2.
- K071399: Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS Insertion Tool, DVS-D-a: DVS Dosimeter, DVS-R-100, Sicel Technologies, Inc. (2007) Summary page 2.
- K080004: Dose Verification System Patient Dosimetry System, Sicel Technologies, Inc. (2008) Summary page 2.

## Most influential descendants
- K141154: Oartrac System (2014), 3 descendants of its own
- K150719: OARtrac System with Skin Sensors (2015), 2 descendants of its own
- K162954: OARtrac System with Patient Specific Reusable Universal PSD Sensors (2017), 1 descendant of its own
- K182395: OARtrac System (2019), 0 descendants of its own

## Indications for use
The DVS (Dose. Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient. The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.

Source page: https://510kreport.com/device/K083035
Methodology: https://510kreport.com/methodology