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510(k) Data Aggregation

    K Number
    K040376
    Device Name
    SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE
    Manufacturer
    SECTRA-IMTEC AB
    Date Cleared
    2004-05-04

    (77 days)

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

    SECTRA-IMTEC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sectra IDS5 device is intended for the manipulation and displaying of x-ray images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
    Device Description
    The Sectra IDS5 Radiology Workstation with Sectra 3D and MPR Packages is mainly a software product. It is used for visualization and processing of digital radiology images. The IDS5 is used as a client together with a Sectra provided server (Class 1 Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used. The Sectra IDS5 Radiology Workstation is in fact a family of devices, including several workstations or types of workstations, e.g. the following: - Primary diagnostics workstation and the most powerful version of IDS5. It contains . tools for assisting the radiologist in making a diagnosis. - . Dedicated workstation for mammography. It has all functionality as an IDS5/dx.net but with an additional mammography package. - . Quality assurance workstation, mainly used by the technologists to prepare the images for the reviewing radiologist. - Clinicians workstation used by the clinicians within the hospital to view the radiology . images and to read the radiology report. - "Web" workstation that can be used by remote clinics to view images and radiology . reports. - . "At-home" workstation that can be used by the radiologist over a low bandwidth connection.
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    K Number
    K033712
    Device Name
    MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1
    Manufacturer
    SECTRA-IMTEC AB
    Date Cleared
    2003-12-23

    (27 days)

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

    SECTRA-IMTEC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sectra IDS device is intended for the manipulation and displaying of x-ray images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
    Device Description
    The IDS5 Radiology Workstation with IDS5/mx.net is mainly a software product. It is used for visualization and processing of digital radiology images. The system runs under the Window 2000 and Windows XP operating system. The requirements on hardware are quite ordinary for a system used for displaying images. Most notably up to four monitors can be used.
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    K Number
    K031590
    Device Name
    SECTRA ORTHOPEDIC PACKAGE
    Manufacturer
    SECTRA-IMTEC AB
    Date Cleared
    2003-10-02

    (134 days)

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

    SECTRA-IMTEC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up. Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
    Device Description
    Sectra Orthopedic Package is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning the templates, and tools for measurements in the images. More specifically the Sectra Orthopedic Package shall: (1) assist the orthopedic surgeons in choosing which implants to use, (2) assist the orthopedic surgeons in choosing were to place cut lines etc., and (3) assist the orthopedic surgeons in following-up of surgical procedures.
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    K Number
    K021527
    Device Name
    SECTRA OSTEOPOROSIS PACKAGE
    Manufacturer
    SECTRA-IMTEC AB
    Date Cleared
    2002-06-07

    (28 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    SECTRA-IMTEC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use to estimate bone mineral density ("BMD") in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization ("WHO") criteria. The device is indicated specifically for use to: (1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis, together with other known risk factors (e.g., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of vitamin D and/or calcium, and smoking); and (2) compare the BMD estimate with a reference population comprised of young normals and age-matched normals to compute T-scores and Z-scores, respectively.
    Device Description
    The Sectra Osteoporosis Package is intended for use to estimate bone mineral densitv (BMD) in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization (WHO) criteria. Sectra Osteoporosis Package features: - indirect "DICOM capability" via the Sectra IDS5 Radiology workstation, i.e. it uses digital image data according to the DICOM standard. - . single screen user interface reached via a right click on an image in a Sectra IDS5 Radiology Workstation. - operates in two modes: Clinical mode and Research mode.
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    K Number
    K002936
    Device Name
    MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
    Manufacturer
    SECTRA-IMTEC AB
    Date Cleared
    2000-10-17

    (26 days)

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

    SECTRA-IMTEC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983447
    Device Name
    WISE (II) IMAGE MANAGEMENT SYSTEM
    Manufacturer
    SECTRA-IMTEC AB
    Date Cleared
    1998-10-29

    (29 days)

    Product Code
    LMB
    Regulation Number
    892.2010
    Why did this record match?
    Applicant Name (Manufacturer) :

    SECTRA-IMTEC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sectra AB WISE II Image Management System device is intended for the management and displaying of x-ray images, other radiological objects and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devicesusing DICOM or similar interface standards.
    Device Description
    WISE II is a system for managing digital radiological images. This includes image storage and searching for images in archives and retrieving image for re-consultation. WISE II generally provides functions to: - Access information related to requests, examinations and images . - Create, move, copy and delete folders and examination folders . - Add images to and delete images from examinations . - File examinations to the archives and retrieve examinations from the archives ● - Retrieve examinations from DICOM conformant archives ● - Manage images stored on multiple file servers - Provide services (DICOM, WWW, etc) to clients via WISE gateways ● - . Interface RIS for relational integrity - . Send and retrieve images (teleradiology)
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    K Number
    K965161
    Device Name
    SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
    Manufacturer
    SECTRA-IMTEC AB
    Date Cleared
    1997-03-12

    (79 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SECTRA-IMTEC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963395
    Device Name
    IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
    Manufacturer
    SECTRA-IMTEC AB
    Date Cleared
    1996-10-25

    (58 days)

    Product Code
    LMB
    Regulation Number
    892.2010
    Why did this record match?
    Applicant Name (Manufacturer) :

    SECTRA-IMTEC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ImageServer 2000 System will be used for digitally store images for archival together with informaton about the images.
    Device Description
    The ImageServer 2000 System will be used for digitally store images for archival together with informaton about the images.
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    K Number
    K961983
    Device Name
    TRS 2000 TELERADIOLOGY SYSTEM
    Manufacturer
    SECTRA-IMTEC AB
    Date Cleared
    1996-08-13

    (85 days)

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

    SECTRA-IMTEC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRS 2000 system is a teleradiology system/transmission and advance reviewing station X-ray images. TRS 2000 is used for advanced reviewing and transmission over private or public telecommunications networks of radiological images.
    Device Description
    The TRS 2000 system is a teleradiology system/transmission and advance reviewing station X-ray images.
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