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Found 4 results
510(k) Data Aggregation
K Number
K123152Device Name
VITESSE 3.0
Manufacturer
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
Date Cleared
2012-12-07
(59 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K103394Device Name
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
Manufacturer
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
Date Cleared
2011-01-12
(54 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barcode Conical Collimator Verification device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place.
Device Description
The Barcode Conical Collimator Verification (BCCV) device provides verification of conical collimators for the Varian High Energy Clinac (K100890) and TrueBeam (K092871) devices. Conical collimators are used during stereotactic radiodurgery (SRS) treatments to deliver small diameter treatment beams. The BCCV will prevent treatment until the conical collimator, as required by the treatment plan, has been scanned.
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K Number
K101294Device Name
PT2 VARIAN PROTON THERAPY SYSTEM
Manufacturer
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
Date Cleared
2010-12-27
(231 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PT2 Varian Proton Therapy System, provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatmont is indicated.
Device Description
PT2 Varian Proton Therapy System is a proton radiation therapy system which delivers therapeutic radiation in accordance with a physician's prescription. The system consists of four major components, 1) Cyclotron required to generate the photon beam 2) Beam line - transports beam from the cyclotron to the required treatment room 3) Up to 4 radiation treatment rooms 4) Treatment Control room
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K Number
K101751Device Name
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
Manufacturer
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
Date Cleared
2010-08-10
(49 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Device Description
The UNIQUE is a Single Energy Linear Accelerator and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. UNIQUE is supported by the following Varian accessories: RPM Respiratory Gating (063270), PortalVision (K091209), 4D Integrated Treatment Console (K091132), Millennium Multi-Leaf Collimator (K050442).
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