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Found 3 results
510(k) Data Aggregation
K Number
K092550Device Name
TIGRT IVS
Manufacturer
LINATECH, LLC
Date Cleared
2009-12-15
(118 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
LINATECH, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.
Device Description
TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.
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K Number
K090893Device Name
TIGRT TPS
Manufacturer
LINATECH, LLC
Date Cleared
2009-07-15
(106 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
LINATECH, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. TiGRT TPS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray and/or electron energies from 1 to 25MV, as well as Cobalt-60.
Device Description
TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. TiGRT TPS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray and/or electron energies from 1 to 25MV, as well as Cobalt-60.
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K Number
K090802Device Name
TIGRT MLC, TIGRT DMLC
Manufacturer
LINATECH, LLC
Date Cleared
2009-07-07
(105 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
LINATECH, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TIGRT MLC 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
TIGRT MLC 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.
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