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510(k) Data Aggregation
K Number
K082909Device Name
RSVP HALF SPHERE PHANTOM, MODEL DDP010
Manufacturer
Date Cleared
2008-12-23
(84 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
THE PHANTOM LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RSVP Half Sphere Phantom™ is designed for verification of therapy dose delivery in radiation therapy machines, specifically the Leksell™ Gamma Knife sterotactic radiosurgery system. The phantom can also be used for periodic quality assurance evaluations and acceptance testing, and to perform reevaluations after equipment or software upgrades. The phantom works in conjunction with commercially available ion chambers, which are not manufactured by the Phantom Laboratory.
Device Description
The RSVP Half Sphere PhantomTM was developed to provide localization and dose verification for radiation therapy machines, specifically the LeksellTM Gamma Knife stereotactic radiosurgery system. The phantom's design provides full simulation of the localization and irradiation sequences. The hemi-spherical shape is formed from a urethane material and filled with water to simulate the radiation absorption and scatter of human soft tissue.
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K Number
K081760Device Name
RSVP PHANTOM PELVIS, MODEL TLP260
Manufacturer
Date Cleared
2008-07-29
(39 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
THE PHANTOM LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RSVP Phantom™ Pelvis is designed for use in a variety of radiation therapy applications including, final quality verification of therapy dose delivery and for comparing the delivered dose profiles for different treatment plans. It is also used for periodic quality assurance evaluations and acceptance testing and to perform reevaluations after equipment or software upgrades.
Device Description
The RSVP Phantom™ Pelvis provides isodose distribution and verification information for both conventional and intensity modulated radiation therapy machines. The life-size pelvic shape is formed from CAB material and filled with water to simulate the radiation absorption and scatter of human soft tissue.
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K Number
K002840Device Name
MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM
Manufacturer
Date Cleared
2000-11-17
(66 days)
Product Code
Regulation Number
892.1600Why did this record match?
Applicant Name (Manufacturer) :
THE PHANTOM LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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