Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K103193
    Device Name
    DOSEVIEW 3D
    Manufacturer
    STANDARD IMAGING, INC.
    Date Cleared
    2010-12-27

    (59 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANDARD IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DoseView 3D system is a 3 axis, water phantom scanning system intended to easily and accurately, measure and analyze pulsed photon and electron radiation from a linear acceleratedbased radiation therapy system or continuous radiation from a radioactive source-based radiotherapy system. This data is then often used in support of a radiation treatment planning system. It is comprised of a water tank, electrometer, radiation detector(s), motion controller, controlling software, master pendant and lift/reservoir cart. It is a prescription device intended to be used by a trained medical physicist. The general uses of the DoseView 3D include the following: - Acceptance testing and/or commissioning of a radiation therapy or radiotherapy system. - Quality assurance measurements to identify and minimize the sources of uncertainty and error in the radiation therapy system, radiotherapy system or radiation treatment planning system. - Collection of dose depth data for radiation treatment planning system use. - Completion of clinical dosimetry protocols and calibrations.
    Device Description
    The DoseView 3D system is a 3-axis, water phantom scanning system intended to easily and accurately, measure and analyze pulsed photon and electron radiation from a linear accelerated based radiation therapy system or continuous radiation from a radioactive source-based radiotherapy system. This data is then often used in support of a radiation treatment plasot system. It is comprised of a water tank, electrometer, radiation detector(s), motion controller, controlling software, master pendant and lift/reservoir cart. It is a prescription device intended to be used by a trained medical physicist.
    Ask a Question
    K Number
    K082773
    Device Name
    STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331
    Manufacturer
    STANDARD IMAGING, INC.
    Date Cleared
    2008-11-19

    (58 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANDARD IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products. This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimetric accuracy is adequate for a particular patient. Dose modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.
    Device Description
    IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products. This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimetric accuracy is adequate for a particular patient. IMSure Brachy QA Software independently computes a modeled dose that would be delivered by a high dosc rate (HDR) or low dose (LDR) brachytherapy system to a patient and compares it to the dose predicted by a primary treatment planning system. IMSure Brachy QA Software imports a file produced by a primary HDR or LDR treatment planning system (TPS), in the format of an industry standard Dicom-RT™ or vendor specific file, which contains information about a treatment. The files contain information about applicators or catheters and the associated source information in each catheter, such as source type, source strength, source location and source duration. The files may also contain information about specific calculation points and the dose predicted by the primary planning system, as well as patient specific information. The dose computation algorithm used is a superposition of point or line sources, incorporating 3-D geometrical features of the source construction, as well as radiological features of the source composition. Dosc modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results. After importing a TPS plan, a user may edit the information, adding or modifying source positions, durations (or dwell times), type, or activity strength. Calculation point information may be edited as well. A 3-D view of the applicators, source positions, and calculation point positions is provided. A paper or electronic record can be stored including the final dose computation for each calculation point compared to the dose computed by the TPS, as well as relevant patient information for long term documentation. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information. IMSure Brachy QA Software is provided to the customer on a CD. It requires the Microsoft Windows Operating System 2000 with service pack 2 or better, or XP. Computer system requirements include Pentium III or equivalent, a minimum of 256 MB RAM and 100 MB available hard drive space. Display requirements include 1024 x 768 minimum resolution and an OpenGL compatible video card meeting OpenGL 1.1 specifications.
    Ask a Question
    K Number
    K060532
    Device Name
    HDR 1000 PLUS WELL CHAMBER, MODEL 90008
    Manufacturer
    STANDARD IMAGING, INC.
    Date Cleared
    2006-04-11

    (42 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANDARD IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Standard Imaging HDR 1000 Plus Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of brachytherapy sources, including high-dose-rate (HDR), low-dose-rate (LDR), intravascular (IVB) and electronic (x-ray) sources, with the appropriate calibration from an accredited dosimetry calibration laboratory. Sources must be measured using the appropriate and specific source holder as described in the labeling.
    Device Description
    The Standard Imaging HDR 1000 Plus Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of brachytherapy sources, including high-dose-rate (HDR), low-dose-rate (LDR), intravascular (IVB) and electronic (x-ray) sources, with the appropriate calibration from an accredited dosimetry calibration laboratory. Sources must be measured using the appropriate and specific source holder as described in the labeling. It is recommended that the chamber be calibrated every two years, as is standard practice for other ionization chambers. Initially, the calibration factor is given in the calibration report from an Accredited Dosimetry Calibration Laboratory (ADCL). The measurement of brachytherapy sources requires an electrometer with a calibrated scale for measuring currents in the range from 10-12 A to 10-7A. Alternatively, a calibrated charge scale may be used with timed runs. If integral charge techniques are used with the time determined by the HDR irradiator timer, the contribution from the source transit-time should be taken into account. The HDR 1000 Plus Well Chamber has a vent hole to maintain the internal air at ambient atmospheric pressure. Thus, the readings obtained must be corrected for ambient temperature and pressure to the temperature and pressure of calibration (22º C and 760 mm Hg) at "normal" relative humidity (50% ± 25%non-condensing) in the usual accepted manner. The HDR 1000 Plus Well Chamber has available different inserts for IVB, HDR, LDR and x-ray measurements. The HDR 1000 Plus Well Chamber has a conventional triax connector and cable to be connected to a suitable electrometer. A bias of 300 volts must be applied to the electrometer lowimpedance connection relative to chassis ground. The voltage polarity effect is less than 0.1%. If desired, a second bias level of 150 volts can also be used to determine the ionic recombination loss at 300 V.
    Ask a Question
    K Number
    K042733
    Device Name
    STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
    Manufacturer
    STANDARD IMAGING, INC.
    Date Cleared
    2004-11-15

    (45 days)

    Product Code
    LHO, IXG, IYE, LLZ, LMB, LMD
    Regulation Number
    892.1940
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANDARD IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PIPSpro QA Software System displays, enhances and analyses portal images, and is used in conjunction with commercially available electronic portal imaging detectors (EPIDs). PIPSpro provides numerous measurement tools, image processing routines, statistical analysis and capabilities that are not available in the standard software provided by the EPID suppliers. These include the processing of simulator and portal verification images, analyzing patient registration errors, measuring of image quality from an EPID during installation tests, providing a platform for quality assurance programs in radiation therapy, and tools for writing and editing notes attached to images for easy communication. In this capacity, it can only import images and information.
    Device Description
    PIPSpro QA Software System (Portal Imaging Processing System, professional version) is a stand-alone software program for use on PC computers running under Microsoft Windows 9x/Me/2000/NT/XP. The PC is not supplied with PIPSpro, and must be provided by the user. PIPSpro is supplied on a CD together with a software security key ("dongal" or hard lock) which is inserted into a parallel or USB port on the computer to allow the software to work. PIPSpro does not use, control, or operate any hardware, it is purely a stand-alone software program. AQUA is also a stand-alone software program, consisting of a small part of the PIPSpro system. AQUA includes only those routines required for the analysis of images acquired with the QC-3 phantom, and used for quality control of electronic portal imaging devices The PIPSpro OA Software System, which displays, enhances and analyses portal images, and is used in conjunction with commercially available electronic portal imaging detectors (EPIDs). PIPSpro provides numerous measurement tools, image processing routines, statistical analysis and capabilities that are not available in the standard software provided by the EPID suppliers. These include the processing of simulator and portal verification images, analyzing patient registration errors, measuring of image quality from an EPID during installation tests, providing a platform for quality assurance programs in radiation therapy, and tools for writing and editing notes attached to images for easy communication. In this capacity, it can only import images and information.
    Ask a Question
    K Number
    K040688
    Device Name
    STANDARD IMAGING E.IMRT CALCULATOR
    Manufacturer
    STANDARD IMAGING, INC.
    Date Cleared
    2004-05-11

    (56 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANDARD IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The e.IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use on an appropriately configured personal computer. It is intended to assist the oncologist or medical physicist in creating an optimum electron treatment plan based on the treatment objective for the patient. Using previously established mathematical equations, the e.IMRT Calculator suggests several potential electron beam treatment energy solutions, within user selected parameters, by combining several discrete energies typically available on the linear accelerator(s). It uses previously user gathered or generated depth dose data sets for each electron energy available (4, 6, 9, 12, 15, 16, 18, 20 or 22 MeV) on the user's specific liner accelerator(s) as its primary input. Other inputs involve the identification of the facility, specific linear accelerator(s) and bolus used. The output of the e.IMRT calculator is a hardcopy printout of the suggested electron beam treatment energies, in both numeric and graphical formats. The site, linear accelerator and bolus information are also provided on this printout are the site. The e.IMRT Calculator does not, however, electronically store any patient identification data or information. Inputs involving patient information are only used for hardcopy printouts. Specific electron beam parameters are selected from the solution options provided by the e.IMRT Calculator for non-direct (manual) input into the user's radiation treatment planning system. The treatment planning system then creates a treatment plan based on the treatment objective for the patient, which is reviewed by the attending oncologist for acceptability prior to implementation with a linear accelerator.
    Device Description
    The e IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use on an appropriately configured personal computer. It is intended to assist the oncologist or medical physicist in creating an optimum electron treatment plan based on the treatment objective for the patient. Using previously established mathematical equations, the e.IMRT Calculator suggests several potential electron beam treatment energy solutions, within user selected parameters, by combining several discrete energies typically available on the linear accelerator(s). It uses previously user gathered or generated depth dose data sets for each electron energy available (4. 6, 9, 12, 15, 16, 18, 20 or 22 MeV) on the user's specific liner accelerator(s) as its primary input. Other inputs involve the identification of the facility, specific linear accelerator(s) and bolus used. The output of the e.IMRT calculator is a hardcopy printout of the suggested electron beam The butput of the c.HAN's numeric and graphical formats. The site, linear accelerator and bolus information are also provided on this printout are the site. The e.IMRT Calculator does not, however, electronically store any patient identification data or information. Inputs involving patient information are only used for hardcopy printouts. Specific electron beam parameters are selected from the solution options provided by the e. IMRT Calculator for non-direct (manual) input into the user's radiation treatment planning system. The treatment planning system then creates a treatment plan based on the treatment objective for the patient, which is reviewed by the attending oncologist for acceptability prior to implementation with a linear accelerator.
    Ask a Question
    K Number
    K013548
    Device Name
    STANDARD IMAGING IVB 1000 WELL CHAMBER
    Manufacturer
    STANDARD IMAGING, INC.
    Date Cleared
    2001-11-09

    (16 days)

    Product Code
    KPT
    Regulation Number
    892.1360
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANDARD IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Standard Imaging IVB 1000 Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of high-dose-rate (HDR), low-dose-rate (LDR) and intravascular (IVB) brachytherapy (gamma and beta) sources, with the appropriate (calibration from an accredited dosimetry calibration laboratory. Sources must be measured using the appropriate and specific source holder as described in the IVB 1000 labeling. To check the bremstralung component of a source, the X-Ray Contamination Test Tool, an accessory to the IVB 1000, should be used.
    Device Description
    The Standard Imaging IVB 1000 Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of high-dose-rate (HDR), low-dose-rate (LDR) and intravascular (IVB) brachytherapy (gamma and beta) sources, with the appropriate calibration from an accredited dosimetry calibration laboratory. Sources must be measured using the appropriate and specific source holder as described in the IVB 1000 labeling. To check the bremstralung component of a source, the X-Ray Contamination Test Tool, an accessory to the IVB 1000, should be used. It is recommended that the chamber be calibrated every two years, as is standard practice for other ionization chambers. Initially, the calibration factor is given in the calibration report from an Accredited Dosimetry Calibration Laboratory (ADCL). The measurement of brachytherapy sources requires an electrometer with a calibrated scale for measuring currents in the range from 10-12 A to 10-7A. Alternatively, a calibrated charge scale may be used with timed runs. If integral charge techniques are used with the time determined by the HDR irradiator timer, the contribution from the source transit-time should be taken into account. The IVB 1000 Well Chamber has a vent hole to maintain the internal air at ambient atmospheric pressure. Thus, the readings obtained must be corrected for ambient temperature and pressure to the temperature and pressure of calibration (22º C and 760 mm Hg) at "normal" relative humidity (50% ± 25%non-condensing) in the usual accepted manner. The IVB 1000 has available different inserts for IVB, HDR, LDR and X-Ray contamination measurements. The IVB 1000 Well Chamber has a conventional triax connector and cable to be connected to a suitable electrometer. A bias of 300 volts must be applied to the electrometer low-impedance connection relative to chassis ground. The voltage polarity effect is less than 0.1%. If desired, a second bias level of 150 volts can also be used to determine the ionic recombination loss at 300 V.
    Ask a Question
    K Number
    K002833
    Device Name
    MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
    Manufacturer
    STANDARD IMAGING, INC.
    Date Cleared
    2000-09-28

    (16 days)

    Product Code
    KPT
    Regulation Number
    892.1360
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANDARD IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001825
    Device Name
    STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER
    Manufacturer
    STANDARD IMAGING, INC.
    Date Cleared
    2000-08-02

    (47 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANDARD IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1