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510(k) Data Aggregation
K Number
K031273Device Name
AMERITEK SURE-POINT HDR NEEDLE TEMPLATE
Manufacturer
Date Cleared
2003-07-15
(84 days)
Product Code
Regulation Number
892.5700Why did this record match?
Applicant Name (Manufacturer) :
AMERTEK MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sure-Point™ HDR Needle Template is designed to allow precision ultrasound probe alignment, placement and position retention of HDR needles in cancer treatments. It was designed to work with commercially available high dose rate remote afterloaders. A specific application is the treatment of prostate (or other) cancer.
Device Description
Template for Seeding Device: Probe Stabilization Device. Applicator for Remote Controlled Afterloading Brachytherapy.
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K Number
K030518Device Name
AMERITEK SURE-POINT TRACKER SYSTEM
Manufacturer
Date Cleared
2003-05-20
(90 days)
Product Code
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
AMERTEK MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The major intended use of the Amertek Sure-Point Tracker™ is the same as that of its unmodified predecessors cleared in K011581 and K972152: to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer. The Amertek Sure-Point Tracker 100 also allows data from the use of probe location indicators to be fed directly into the brachytherapy planning program, such as that of Varian.
Like other basic stabilizers and steppers (e.g. Barzell-Whitmore Omnistand; Tayman Accuquide; Teknar, Proscan), this device is applicable in other surqical procedures or specialties which require accurate instrument fixation, such as cryosurgery, biopsy, and remote afterloading equipment (HDR) such as that used with the Nucletron device.
Device Description
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K Number
K011581Device Name
AMERITEK BRACHYTHERAPY TEMPLATE
Manufacturer
Date Cleared
2001-07-17
(55 days)
Product Code
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
AMERTEK MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Amertek Template is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer.
Device Description
Not Found
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