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510(k) Data Aggregation
K Number
K980526Device Name
PHOTON RADIOSURGERY SYSTEM PRS400
Manufacturer
PEC PHOTOELECTRON CORP.
Date Cleared
1998-07-27
(167 days)
Product Code
JAD
Regulation Number
892.5900Why did this record match?
Applicant Name (Manufacturer) :
PEC PHOTOELECTRON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Photon Radiosurgery System is intended to be used for the irradiation on intracranial tumors.
Device Description
The PRS400 Photon Radiosurgery System is a modification of the Photoelectron Corporation PRS Model 3. Modifications have been made to increase radiation safety, improve the user interface with the system, and improve manufacturability of the PRS components. None of the changes affect the function, intended use, or overall design of the PRS. Both devices are complete systems for highly focused treatment of intracranial tumors. The heart of the system is a miniature, high dose rate, low energy X-ray source equipped with a 3.175 mm diameter, 10 cm long interstitial probe. The X-ray source is designed so that the tip of the probe can be positioned precisely into the tumor and a prescribed therapeutic radiation dose delivered in a single fraction. X-rays are emitted from the tip of the PRS' probe in a spherically symmetric pattern and the tumor is destroyed from the inside out. A sterile sheath is placed over the probe prior to insertion into the turnor. The voltage, current, and exposure time of the X-rays are set via the PRS400 Control Console. A complete set of accessories is provided to assist in placement of the interstitial probe and to perform quality control of the X-ray source in the clinical setting. Additional laboratory-based components of the PRS include an automated dosimetry water tank for calibration and a CCD-camera based radio chromic film reader for dose verification.
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