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U.S. Department of Health and Human Services

Product Classification

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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 CodeQUV
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
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible