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Trained medical professionals use Contour ProtégéAl as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAl supports the following indications: · Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Segmenting anatomical structures across a variety of CT anatomical locations. · And segmenting the prostate, the seminal vesicles, and the urethra within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.

Contour ProtégéAl+ is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAl+ is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical image modalities include but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications: - · Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. - · Create, display and print reports from medical images. · Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. · Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. · Localization and definition of objects such as tumors and normal tissues in medical images. · Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. · Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). · Calculating absorbed radiation dose as a result of administering a radionuclide. • Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success. When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If using with unapproved ones, this device should only be used for research purposes. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDAapproved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

MIM - Symphony HDR Fusion extends the existing features and capabilities of MIM -Monte Carlo Dosimetry (K232862) by offering enhanced capabilities to better support the High Dose Rate (HDR) brachytherapy workflow. It is designed for use in medical imaging and operates on Windows, Mac, and Linux computer systems. The intended use and indications for use in MIM - Symphony HDR Fusion are unchanged from the predicate device MIM – Monte Carlo Dosimetry. MIM – Symphony HDR Fusion is a standalone software application within the MIM software suite that uses the existing functionality of the predicate device, applied now in the context of a High Dose Rate (HDR) brachytherapy clinical workflow. MIM – Symphony HDR Fusion leverages the foundational functionalities that were introduced in the predicate device to support Low Dose Rate (LDR) brachytherapy clinical workflows. These features are extended with necessary enhancements and optimizations to optimally support the HDR workflow. Specifically, the subject device MIM - Symphony HDR Fusion provides the following core processes: - Reslicing and Predictive Fusion presents data to inform the user's placement of medical devices (in this case, brachytherapy applicators). MIM receives and displays 2D images from a Trans-rectal Ultrasound (TRUS) probe and overlays contours from the registered pre-op image volume. The user is able to modify the position of the TRUS probe in the patient in order to match the visible pre-op contours. The user may also manually adjust the registration using software tools. - . Ultrasound Capture: MIM receives an image feed from an US machine and position information from a stepper that holds the TRUS probe. The 2D TRUS images are processed into 3D image volumes-enabling their registration, fusion display, and storage as DICOM objects. - Catheter Digitization provides tools for the user to localize and define HDR . brachytherapy applicators (catheters) in medical images. - Registration Chaining allows the user to transfer information (contours) from the pre-op image (typically MR) through to the final planning image (US or CT). This is achieved using existing rigid registration tools from the predicate device to sequentially register each new image to its immediate predecessor in the clinical workflow. - Export Data: The end of the MIM Symphony HDR Fusion workflow is to export the final planning image and user-defined structures-including organs and brachytherapy applicator models—into DICOM files for use in third-party radiation therapy treatment planning systems. Structured reports may also be created.

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications: · Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. · Create, display, and print reports from medical images. · Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. · Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. · Localization and definition of objects such as tumors and normal tissues in medical images. · Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. · Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). · Calculating absorbed radiation dose as a result of administering a radionuclide. When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes. Lossy compressed mammoaraphic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

MIM - Centiloid Scaling extends the features of MIM - Additional Tracers (K223800). It is designed for use in medical imaging and operates on Windows, Mac, and Linux computer systems. The intended use and indications for use in MIM - Centiloid Scaling are unchanged from the predicate device, MIM - Additional Tracers (K223800). MIM - Centiloid Scaling is a standalone software application that extends the functionality of the predicate device by providing: - · Conversion of SUVr calculations to a standardized Centiloid scale for PET-based amyloid burden measurement with Florbetapir (Amvvid®), Florbetaben (Neuraceq®), and Flutemetamol (Vizamyl™)

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications: - Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. - Create, display, and print reports from medical images. - Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. - Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. - Localization and definition of objects such as tumors and normal tissues in medical images. - Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. - Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. - Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). - Calculating absorbed radiation dose as a result of administering a radionuclide. - Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success. When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

MIM - Monte Carlo Dosimetry (K232862) extends the features of MIM - Ablation (K220256). It is designed for use in medical imaging and operates on Windows, Mac, and Linux computer systems. The intended use and indications for use in MIM - Monte Carlo Dosimetry are unchanged from the predicate device, MIM - Ablation (K220256). MIM - Monte Carlo Dosimetry (K232862) is a standalone software application that extends the functionality of the predicate device by providing: - Dose calculation of radionuclides performed using a Monte Carlo method

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications: - Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. - Create, display, and print reports from medical images. - Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. - Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. - Localization and definition of objects such as tumors and normal tissues in medical images. - Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. - Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. - Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). - Calculating absorbed radiation dose as a result of administering a radionuclide. - Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success. When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

MIM – Dose Analysis extends features of MIM – Ablation (K220256). It is designed for use in medical imaging and operates on both Windows and Mac computer systems. MIM - Dose Analysis is a standalone software application that provides: - Calculation of Biologically Effective Dose (BED) and Equieffective Dose in specified fractions (e.g., EQD2) - Evaluation of radiation dose on different image sets through the use of rigid and deformable registration objects - Accumulation of doses

Trained medical professionals use Contour ProtégéAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications: · Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Segmenting anatomical structures across a variety of CT anatomic locations. · And segmenting the prostate, the seminal vesicles, and the urethra within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAl is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.

Trained medical professionals use Contour ProtégéAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications: · Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transfering contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Segmenting anatomical structures across a variety of CT anatomic locations. · And segmenting the prostate, the seminal vesicles, and the urethra within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAl is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications: · Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. - · Create, display and print reports from medical images. · Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. · Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-systolic volume, and ejection fraction. · Localization and definition of objects such as tumors and normal tissues in medical images. · Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. · Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). - · Calculating absorbed radiation dose as a result of administering a radionuclide. When using this device clinically within the United States, the user should only use FDA-approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

MIM - Additional Tracers is an expansion of the standalone software application MIM -On Linux (K190379). MIM - Additional Tracers Indications for Use have not been modified, and the Intended Use is the same as in MIM - On Linux. With the addition of additional tracers to the standalone MIM software, engineering drawings, schematics, etc. are not applicable to the device. These Indications for Use include quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. MIM - Additional Tracers includes the above features and capabilities and adds support for new PET/SPECT new tracers. While MIM - On Linux supported FDG and HMPAO tracers, this special 510k submission includes new tracers support for: Amyvid™ (Florbetapir), Vizamyl™ (Flutemetamol), Neuraceq™ (Florbetaben), and DaTscan™ (Joflupane). MIM - Additional Tracers operates on Windows, Mac, and Linux computer systems.

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications: · Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. · Create, display and print reports from medical images. · Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. · Evaluation of cardiac left ventricular function, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. · Localization and definition of objects such as tumors and normal tissues in medical images. · Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Quantitative and statistical analysis of PE7/SPECT brain scans by comparing to other registered PET/SPECT brain scans. · Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). · Calculating absorbed radiation dose as a result of administering a radionuclide. · Assist with the planning and evaluation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success. When using device clinically, within the United States, the user should only use FDA approved radionly, If using with unapproved ones, this device should only be used for research purposes. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

MIM - Ablation is a standalone software application that allows for the planning and evaluation of ablation procedures. This is achieved by utilizing the following functionality: - . Manual and automatic tools for normal structure, target region, and ablation zone segmentation - lmage re-slicing and reorientation orthogonally to a user-defined angle to give a . "probe's-eye view" image for planning - Manual and constraint-driven placement of virtual ablation devices on medical . imaging in order to visualize the ablation energy zones. - . The calculation of the percentage of designated structures that are covered by each energy zone during planning, as well as a calculation of the final ablation zone coverage after the ablation has been performed - Multimodality image registration, including rigid and deformable fusion, for the . comparison of images taken at different times during the ablation planning and treatment administration MIM - Ablation is run on a dedicated workstation in the hospital healthcare environment and can be used with an 3D DICOM image. The software can be used on image data for any patient demographic that is undergoing ablation treatment with devices validated for inclusion in MIM - Ablation.

Trained medical professionals use Contour ProtégéAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications: · Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transfering contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Segmenting normal structures across a variety of CT anatomical locations. · And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.

Contour ProtégéAl is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAl is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.