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510(k) Data Aggregation

    K Number
    K230393
    Device Name
    UniCam Evo Software
    Manufacturer
    Inter Medical Medizintechnik GmbH
    Date Cleared
    2023-04-13

    (58 days)

    Product Code
    LLZ, 21C
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inter Medical Medizintechnik GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UniCam Evo Software package is indicated for nuclear medicine image post-processing software for scinitigraphic and SPECT imaging. UniCam Evo is indicated for processing and quantification of planar and tomographic bone scintigraphy scans, processing of cerebrovascular scintigraphic scans, processing of planar and tomographic cardiovascular scintigraphic studies, renal dynamic scans, planar and SPECT lung scintigraphy, planar gastrointestinal scintigraphic scans, liver scintigraphy, thyroid scintigraphy and displaying multimodal image fusion between SPECT/CT/MR/PET/ultrasound modalities.
    Device Description
    UniCam Evo is a software package for processing planar, whole body, dynamic planar and SPECT nuclear medicine data sets. The UniCam Evo Software is used for digital images capture, pre-processing, saving, post-processing, multiplanar reconstruction, multimodal image fusion, multimodal image registration, 3D rendering, viewing, archiving and transferring between image viewing workstations. The UniCam Evo Software is intended for nuclear medicine specialists, nuclear medicine radiologists, or trained medicine technologists. The operator shall have basic computer operation skills. The software loads scintigraphic data sets in Dicom 3.0 format from the local database or queries the corresponding dicom data from a PACS archive. The operator may perform analysis on the data, ROI analysis, tomographic reconstruction, organ dependent procedure steps and the software displays the results in form of images, numerical data or curves. The operator may print the results, store as an image or dicom secondary capture. Reconstructed transversal, coronal and sagittal slices can be also stored in Dicom format. The data to be processed can be transferred via the DICOM 3.0 Standard to another Nuclear Medicine Workstations of another Manufacturer or from a Gamma Camera / SPECT acquisition workstation. The software runs under standard Windows operating systems, such as XP, 7, 8, 10, 11.
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    K Number
    K132347
    Device Name
    MULTICAM 3000 ECO
    Manufacturer
    INTER MEDICAL MEDIZINTECHNIK GMBH
    Date Cleared
    2013-11-20

    (114 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTER MEDICAL MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MultiCam 3000 eco is intended to detect and obtain Planar and SPECT images of the distribution of a gamma emitting radionuclide in the organs or bone and store the data, when the radionuclide is administered in the body.
    Device Description
    The MultiCam 3000 eco consist of the gantry with 3 Gamma Camera detectors, a patient table together with an Acquisition Workstation. The Performance or Quality assurance can be done on the Acquisition Workstation with the integrated quality software or on the connected Processing Workstations. The data will be transferred via the DICOM 3.0 Standard to a Nuclear Medicine Workstations of another Manufacturer, where the patient documentation will be done. The signal processing is done similar to the existing Prism 3000 or the CX 250 but on one high integrated board - LQN - which provides the Detector data via TCP/IP network to the Acquisition Computer. Also in the MultiCam 3000 eco a Nal crystal is used with 49 Photomultiplier. The Field of View is 13" x 7,9". For the system there are 7 different collimators are optional available. The collimator exchange can be done manual. Each collimator has its own collimator switch which disables the dedicated motion over a separate electronic circuitry. The function of the collimator is also checked continuously by this safety circuits. The patient monitor is used for patient positioning. It consists of a color monitor for the display of the patient study during acquisition. Additional on it is a window with numeric information for the gantry motion information and the collimator information. It shows also Warning - and Error - Messages of the gantry. Functional characteristics: Each photomultiplier is precisely digitized with a resolution of 18 bit ADC's. No electronic is anymore needed on the photomultiplier. The output of all 3 detectors are combined in a 1000 Mbit switch and connected over a proprietary TCP/IP network to the Acquisition Computer.
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    K Number
    K052473
    Device Name
    CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
    Manufacturer
    INTER MEDICAL MEDIZINTECHNIK GMBH
    Date Cleared
    2005-10-28

    (49 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTER MEDICAL MEDIZINTECHNIK GMBH

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