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The Sectra MicroDose Mammography L30 is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Sectra MicroDose Mammography L30 is intended to be used in the same clinical applications as traditional film/screen systems.

The Sectra MicroDose Mammography L30 is a type of full-field digital mammography system comprised of an image acquisition system, a gantry and an acquisition workstation computer equipped with a keyboard, a keypad, a mouse, and a monitor. The image acquisition system includes a digital detector of photon counting technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression paddle(s), and multi-slit collimator. The acquisition workstation is the user interface for preparing and initiating image acquisition, image processing, and image transfer to the desired destination (e.g. PACS) for diagnosis and archiving. The Sectra MicroDose Mammography 130 detector is based on photon counting technology and consists of a large number of crystalline silicon strip detectors. The technology enables high detection efficiency of photons and efficient rejection of electronic noise. The Sectra MicroDose Mammography L30 uses a multi-slit scanning technique that prevents image degradation caused by scattered radiation by removing photons scattered in the breast and not directed towards the detector. These factors combine into a dose efficient system. The Sectra MicroDose Mammography L30 provides three exposure modes; manual, automatic (parameters predefined based on compressed breast thickness), and SmartAEC. SmartAEC continuously adjusts the exposure based on measured transmission from the leading detector edge.

The Sectra Workstation is intended for the manipulation and displaying of medical 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. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

The Sectra Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The Sectra Workstation is used as a client together with a Sectra provided server (Sectra PACS Core, Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used. The Sectra Workstation is a family of devices, including several workstations or types of workstations (see Table 1).

The Sectra Workstation is intended for the manipulation and displaying of medical 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. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.

The Sectra Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The Sectra Workstation is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used. The Sectra Workstation is a family of devices, including several workstations or types of workstations. | Workstation<br>type | Description | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | IDS5/dx.net | A diagnostics workstation. It contains tools for assisting the radiologist<br>in making a diagnosis. | | IDS5/mx.net | The dedicated workstation for mammography. It has all functionality<br>as an IDS5/dx.net but with additional mammography features. | | | Note! Reading of mammographic images shall only be<br>conducted with IDS5/mx.net. | | IDS5/qa.net | The quality assurance workstation in the Sectra Workstation family.<br>Mainly used by the technologists to prepare the images for the<br>reviewing radiologist. | | IDS5/mqa.net | New! The quality assurance workstation to be used by a<br>mammography technician to prepare images for the reviewing<br>radiologist. | | IDS5/cl.net | Used by the clinicians within the hospital to view the radiology images and to read the radiology report. | | IDS5/web | A slim version of the Sectra Workstation that can be used by remote clinics to view images and radiology reports. | | IDS5/home | An at-home workstation of the diagnostics workstation that can be used by the radiologist over a low bandwidth connection. | | IDS5/doc | A limited workstation that is used to scan radiology requests. | | IDS5/send | A teleradiology workstation that is used to send examinations to teleradiology destinations. | | IDS7/dx | <i>New!</i> A diagnostics workstation, based on the new software architecture. It contains tools for assisting the radiologist in making a diagnosis. | To handle specific user needs it is also possible to activate Sectra developed add-ons for the Sectra Workstation. An add-on is thus an additional feature set that can be used on the Sectra Workstation. There are add-ons on Sectra Workstation IDS5 but are included as ordinary features for IDS7. Examples: | Add-on | Sectra Workstation IDS5 | Sectra Workstation IDS7 | |--------------------------------------------------------|-------------------------|------------------------------| | Volume rendering (3D) | X | X | | Clinical Application<br>Interface slots (2 additional) | X | | | Dual monitor support | X | Included in IDS7 by default. | | Multiframe support | X | Included in IDS7 by default. | | Image cache | X | Included in IDS7 by default. | | DICOM print support | X | | | Image scanner support | X | | | Basic document scanner<br>support | X | | | Demonstration scheduling | X | | | Nuclear medicine image<br>controls | X | | | Patient CD | X | |

The Sectra IDS5 device is intended for the manipulation and displaying of medical 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. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

The Sectra IDS5 Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The IDS5 is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used. The Sectra IDS5 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 -. IDS5/dx.net. It contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis. - Dedicated workstation for mammography IDS5/mx.net. It has all functionality as an . IDS5/dx.net but with an additional mammography package. Reading of mammographic images shall only be conducted with IDS5/mx.net. - 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 medical . images and to read the report. - . "Web" workstation that can be used by remote clinics to view images and reports. - "At-home" workstation that can be used by users, e.g. radiologists, over a low . bandwidth connection.

The Sectra IDS5 device is intended for the manipulation and displaying of medical 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. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

The Sectra IDS5 Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The IDS5 is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used. The Sectra IDS5 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 -IDS5/dx.net. It contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis. - Dedicated workstation for mammography IDS5/mx.net. 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 medical ● images and to read the report. - "Web" workstation that can be used by remote clinics to view images and reports. . - "At-home" workstation that can be used by users, e.g. radiologists, over a low . bandwidth connection.