# K202928: DV. Target

- Pathway: 510(k) (Traditional)
- Applicant: Deepvoxel, Inc.
- Decided: Apr 2, 2021 after 185 days
- Product code: QKB (Radiological Image Processing Software For Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913770 (1991). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181572: Workflow Box, Mirada Medical, Ltd. (2018) Summary page 5.

## Indications for use
DV.Target is a software application that enables the routing of DICOM-compliant data (CT Images) to automatic image processing workflows, using machine learning-based algorithms to automatically delineate organs-at-risk (OARs). Contours generated by DV.Target may be used as an input to clinical workflows for treatment planning in radiation therapy. DV.Target is intended to be used by trained medical professionals including radiologists, radiation oncologists, dosimetrists, and physicists. DV.Target does not provide a user interface for data visualization. Image data uploaded, auto-contouring results, and other functionalities are managed via an administration interface. Thus, it is required that DV.Target be used in conjunction with appropriate software, such as a treatment planning system (TPS), to review, edit, and approve for all contours generated by DV.Target. DV.Target is only intended for normal organ contouring, not for tumor or clinical target volume contouring.

Source page: https://510kreport.com/device/K202928
Methodology: https://510kreport.com/methodology