| Device |
phase-changing fiducial marker for radiation therapy |
| Definition |
A phase-changing fiducial marker for radiation therapy is a single-use, sterile liquid material that changes phase in situ when injected in tissue for the purposes of aiding radiation therapy treatment. The device is intended to be visualized using one or more radiologic imaging modalities. |
| Physical State |
Synthetic, implantable sterile material, supplied for single use. Modified in situ from its liquid form to create a gel-like fiducial marker in vivo. |
| Technical Method |
Implanted via image guided injection into tissue(s) of the body relevant for radiotherapy planning at a healthcare facility. The injected material is modified in situ from its original form to create a gel-like marker. Upon formation, the marker is visible on radiologic imaging modalities (X-ray, ultrasound, etc.) for the purposes of aiding patient positioning for radiation therapy treatment |
| Target Area |
Tissue |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | QUV |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Division of Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.5727
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
