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510(k) Data Aggregation
K Number
K022411Device Name
PRECISEPLAN 2.0
Manufacturer
Date Cleared
2002-09-20
(58 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PRECISION THERAPY INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PrecisePLAN® Treatment Planning System is intended to be used for planning the dosimetry of treatments in radiation therapy. PrecisePLAN® provides 2 and 3 dimensional planning capabilities based upon user defined treatment plan parameters. As an option, the user may elect to use weight optimization functionality that suports Intensity Modulated Radiaton Therapy (IMRT). Using the IMRT functionality extends the 3-D conformal planning where geometric shaped apertures are created to cover target structure(s) and minimize exposure to surrounding organs at risk. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.
Device Description
PrecisePLAN® 2.00 is an enhancement to the PrecisePLAN® 1.00, which has previously been cleared for commercial distribution (K002240 8/23/2000). This enhancement to PrecisePLAN® does not raise additional types of safety or effectiveness considerations.
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K Number
K002240Device Name
RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
Manufacturer
Date Cleared
2000-08-23
(30 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PRECISION THERAPY INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K992864Device Name
RENDER-PLAN 3-D
Manufacturer
Date Cleared
1999-09-09
(15 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PRECISION THERAPY INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Render-Plan 3-D® is intended to be used for planning the dosimetry of treatments in radiation therapy. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.
Device Description
The Render-Plan 3-D® is an enhancement to the Render-Plan 3-D 1) (Formerly known as Renner-Plan) which has previously been cleared for (Formerly Known as Renner-Frish) winest (1999). This enhancement to Render-Plan 3-De does not raise additional types of safety of effectiveness considerations.
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