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Phase-Changing Fiducial Marker For Radiation Therapy

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.5727
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QUV is linked to regulation 21CFR892.5727, which does not seem to exist yet. It may be pending at the moment.

Phase-Changing Fiducial Marker For Radiation Therapy

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.5727
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QUV is linked to regulation 21CFR892.5727, which does not seem to exist yet. It may be pending at the moment.