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510(k) Data Aggregation
K Number
K091230Device Name
HDR PROSTATE TEMPLATE AND ACCESSORIES
Manufacturer
PHOTON TECHNOLOGIES CORPORATION
Date Cleared
2009-08-12
(107 days)
Product Code
JAQ
Regulation Number
892.5700Why did this record match?
Applicant Name (Manufacturer) :
PHOTON TECHNOLOGIES CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HDR ProstateTemplate and Accessories are indicated for use as an accessory to commercially available high dose rate remote afterloading systems for prostate brachytherapy.
Device Description
The Photon Technologies HDR Prostate Template and Accessories are designed to work as accessories to commercially available high dose rate remote afterloader systems and consists of a template, plastic needles and needle obturators. The template is designed to mount on various ultrasound stepping devices and the grid of needle sized holes is compatible with the standard ultrasound image grid. The template is also designed with a simple locking mechanism for holding the needles in place and suture holes for suturing the template to the patient. The needle is a plastic tube that is closed to a sharp point at one end and equipped with a metal connector for attaching the needle to the remote afterloader transfer tube on the open end. The needle obturator is a spring temper metal rod that is inserted into the needle before use to straighten and stiffen it before implantation and to prevent damage between treatments or the possible entry of bodily fluids or other foreign matter. The HDR Prostate Template and Accessories are single use accessories that are provided unsterile and whose components are compatible with steam autoclave sterilization.
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