# DEN220017: BioXmark

- Pathway: De Novo (Direct)
- Applicant: Nanovi A/S
- Decided: Dec 23, 2022 after 294 days
- Product code: QUV (Phase-Changing Fiducial Marker For Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5727
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
BioXmark is indicated for use to radiographically mark lung, bladder and lymph nodes in adult patients for whom it has been determined that radiographical marking of tissue for radiation treatment is indicated for their cancer treatment. BioXmark is implanted via image guided injection into tissue relevant for radiotherapy planning at a healthcare facility. BioXmark can be implanted in the tumor, lymph nodes or tissue adjacent to the tumor subject to irradiation or healthy tissue which should not be irradiated. BioXmark is intended to mark tissue for at least 3 months after implantation.

Source page: https://510kreport.com/device/DEN220017
Methodology: https://510kreport.com/methodology