# K052118: Dose Verification System

- Pathway: 510(k) (Traditional)
- Applicant: Sicel Technologies, Inc.
- Decided: Apr 3, 2006 after 242 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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). 9 ancestors in all.
8 later devices descend from it; 4 cite 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)
- K932598: TN-RD-50, Keithley Instruments, Inc. (1994) Summary page 2.
- K013279: Mosfet Autosense, Model TN-RD-60, Thomson & Nielsen Electronics, Ltd. (2001) Summary page 2.
- 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.
- K041557: Mobilemosfet Wireless Dosimetry System, Model TN-RD-70-W, Thomson & Nielsen Electronics, Ltd. (2004) Summary page 2.
- K040687: Onedose Patient Dosimetry System, Sicel Technologies, Inc. (2004) Summary page 2.
- K925416: Symbiosis Bone Marrow Biopsy Needle, Symbiosis Corp. (1993) Summary page 2.

## Most influential descendants
- 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
- K141154: Oartrac System (2014), 3 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 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/K052118
Methodology: https://510kreport.com/methodology