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510(k) Data Aggregation
(261 days)
The PRO-DOSE System is intended to provide dosimetry or detect in real-time the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of HDR brachytherapy after-loaders involving Iridium-192 sources.
The PRO-DOSE System is intended to provide dosimetry or detect in real-time the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of HDR brachytherapy after-loaders involving Iridium-192 sources.
It is designed to measure the total dose and dose rate administered to patients during radiation therapy treatments. It enables real-time, in vivo monitoring throughout the treatment and generates a Dosimetry Report upon completion.
The Reading Device allows simultaneous dosimetry measurements in up to three independent positions by using three probes.
The System can be operated via an Software Graphical User Interface (GUI) that runs on the MiniPC, which functions in kiosk mode to ensure secure and exclusive use. The Software is pivotal in controlling the Reading Device, processing the signal and displaying measurements. As treatment progresses, real-time dose and dose rate measurements are provided. It also allows for the export of a Dosimetry Report as PDF files for documentation and review. The Probes allow instant detection and quantification of radiation dose. These probes are strategically placed at predefined locations by the user to ensure optimal monitoring throughout the treatment. The probes are single-use and pre-calibrated. Due to their small size and water equivalence, these probes can be inserted into the patient body using the same techniques through needles used in the HDR brachytherapy treatments.
The real-time radiation dose data is intended for use by qualified and trained personnel who recognize radiation hazards associated with the use of radiation therapy and radiology equipment. The system does not interact with the radiation source and is solely designed to monitor and report the accuracy of the treatment delivery. It does not deliver, plan, simulate, or control the radiation delivery. The trained and qualified user is responsible for the interpretation of the information.
The current version of PRO-DOSE System is specifically suitable for monitoring High Dose Rate (HDR) Brachytherapy treatments involving Iridium-192 sources.
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