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510(k) Data Aggregation
K Number
K060187Device Name
TOPSLANE DMLC
Manufacturer
Date Cleared
2006-07-27
(184 days)
Regulation Number
892.5710Why did this record match?
Applicant Name (Manufacturer) :
TOPSLANE INTERNATIONAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
Device Description
TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the various linear accelerator. It comprises multiple motorized tungsten leafs and By controlling each leaf to the designed position according to the software. treatment planning system (TPS), TOPSLANE DMLC is intended to shape the specific field, either in static or dynamic mode. TOPSLANE DMLC can perform different field shaping methods, such as Static Field Shaping, or Step and Shoot IMRT Field Shaping or Sliding Window IMRT Field Shaping.
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K Number
K963451Device Name
ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING
Manufacturer
Date Cleared
1997-08-05
(336 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
TOPSLANE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ARTP (Anti-Tumor Radiation Treatment Planning System) is a radiation dose planning and simulation of patients undergoing external beam treatment in the oncology clinic. ARTP is used to plan and simulate radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
Device Description
The TOPSLANE ATES is a Radiotherapy Treatment Planning System (RTPS) for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ATES is using modem photon beam convolution dose calculation algorithm and electron pencil beam dose calculation algorithm. The system software is designed to be convenient and low cost to the user.
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