Phase-Changing Fiducial Marker For Radiation Therapy

QUV · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.5727

Classification

FDA Product Code: QUV
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.5727
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown