MIM - Centiloid Scaling

K233620 · Mim Software, Inc. · LLZ · May 20, 2024 · Radiology

Device Facts

• Record ID: K233620
• Device Name: MIM - Centiloid Scaling
• Applicant: Mim Software, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 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.

Device Story

MIM - Centiloid Scaling is a standalone software application extending the MIM - Additional Tracers platform. It processes PET brain scan images to quantify amyloid burden. The device inputs DICOM-compliant PET images; it performs automated registration to a standard template and calculates Standardized Uptake Value ratios (SUVr). These SUVr values are transformed into a standardized Centiloid scale using tracer-specific linear regression equations for Florbetapir, Florbetaben, and Flutemetamol. The software operates on Windows, Mac, and Linux systems in clinical environments. Physicians use the output—a Centiloid value—to assess amyloid plaque burden, aiding in the evaluation of patients with cognitive impairment. The device provides a standardized metric to facilitate consistent interpretation across different tracers and imaging sites, potentially improving diagnostic accuracy and clinical management of neurodegenerative conditions.

Clinical Evidence

Bench testing only. Accuracy of Centiloid quantification validated using GAAIN database cohorts and clinical trial data (ADNI2, Phase II trials). Primary endpoints included linear regression correlation (R² > 0.96 for all three tracers) against GAAIN-published SUVr values and classification accuracy against consensus expert visual reads. Combined accuracy was 95.1% (range 92.0-98.7%) with a Kappa of 0.90 (range 0.84-0.97). Bland-Altman analysis confirmed minimal bias (<1.51 Centiloids).

Technological Characteristics

Standalone software application; runs on Windows, macOS, and Linux. Supports ACR/NEMA DICOM 3.0 imaging modalities. Implements PET registration pipeline and linear regression-based Centiloid conversion equations. No hardware components. Software-based quantitative analysis.

Indications for Use

Indicated for trained medical professionals (radiologists, oncologists, physicians, technologists, dosimetrists, physicists) to aid in evaluation and management of digital medical images (CT, MR, CR, DX, MG, US, SPECT, PET, XA). Used for image processing, registration, fusion, cardiac function evaluation, contouring, PET/SPECT brain scan analysis, and brachytherapy planning. Contraindicated for primary interpretation of lossy compressed mammographic or digitized film screen images; not for mammography CAD.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• MIM - Additional Tracers (K223800)
• MIM 4.0 (NEURO) (K060816)

Submission Summary (Full Text)

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May 20, 2024

MIM Software Inc. Sydney Lindner Senior Clinical Engineer 25800 Science Park Drive Suite 180 Cleveland, Ohio 44122

Re: K233620

Trade/Device Name: MIM - Centiloid Scaling Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 19, 2024 Received: April 19, 2024

Dear Sydney Lindner:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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## Indications for Use

Submission Number (if known)

K233620

Device Name

MIM - Centiloid Scaling

Indications for Use (Describe)

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 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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" underneath in a smaller font.

#### 25800 Science Park Drive - Suite 180 Cleveland, OH 44122 866-421-2536 www.mimsoftware.com

K233620

510(k) Summary (The following information is in conformance with 21 CFR 807.92)

# Submitter

MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122

| Phone: | 216-455-0600 |
|------------------------|----------------|
| Fax: | 216-455-0601 |
| Contact Person: | Sydney Lindner |
| Date Summary Prepared: | April 19, 2024 |

## Device Name

Trade Name:

Common Name:

Requlation Number / Product Code:

Classification Name:

MIM - Centiloid Scaling

Medical Imaging Software

21 CFR 892.2050 Product Code LLZ

System, Imaging Processing, Radiological

## Predicate Devices

K223800 MIM - Additional Tracers Primary: Secondary: K060816 MIM 4.0 (NEURO)

MIM Software Inc. MIM Software Inc.

### Intended Use

MIM software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists.

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Image /page/4/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a focus on simplicity and readability.

MIM is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print, and process digital medical images, as well as create, display, and print reports from those images. The medical modalities of these medical imaging systems 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 provides the user with the means to display, register, and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.

The Region of Interest (ROI) feature reduces the time necessary for the user to define objects in medical image volumes by providing an initial definition of object contours. The objects include, but are not limited to, tumors and normal tissues.

MIM provides tools to quickly create, transform, and modify 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.

MIM aids in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel-by-voxel basis, within stereotactic surface projections or standardized regions of interest.

MIM allows the dose distribution of an implant to be individually shaped for each patient and is a general-purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using permanent implants of various radioisotopes (not including radioactive microspheres).

MIM allows voxel-based dose calculations for patients who have been administered radioisotopes or radioactive microspheres.

### Indications for Use

MIM software is used by trained medical professionals as a tool to aid in the 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:

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Image /page/5/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it.

- 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 imaqes.
- · 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 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.

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Image /page/6/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a sans-serif font, with the word "SOFTWARE" below it in a smaller font.

| | Subject Device: | Primary Predicate Device: | Secondary Predicate Device: |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ITEM | MIM - Centiloid Scaling<br>(K233620) | MIM - Additional Tracers<br>(K223800) | MIM 4.0 (NEURO)<br>(K060816) |
| Clearance Date | TBD | January 17, 2023 | May 16, 2006 |
| Intended Use | MIM software is intended for<br>trained medical professionals<br>including, but not limited to,<br>radiologists, oncologists,<br>physicians, medical<br>technologists, dosimetrists,<br>and physicists.<br><br>MIM is a medical image and<br>information management<br>system that is intended to<br>receive, transmit, store,<br>retrieve, display, print and<br>process digital medical<br>images, as well as create,<br>display, and print reports from<br>those images. The medical<br>modalities of these medical<br>imaging systems include, but<br>are not limited to, CT, MR,<br>CR, DX, MG, US, SPECT,<br>PET and XA as supported by<br>ACR/NEMA DICOM 3.0. | MIM software is intended for<br>trained medical professionals<br>including, but not limited to,<br>radiologists, oncologists,<br>physicians, medical<br>technologists, dosimetrists,<br>and physicists.<br><br>MIM is a medical image and<br>information management<br>system that is intended to<br>receive, transmit, store,<br>retrieve, display, print and<br>process digital medical<br>images, as well as create,<br>display, and print reports from<br>those images. The medical<br>modalities of these medical<br>imaging systems include, but<br>are not limited to, CT, MRI,<br>CR, DX, MG, US, SPECT,<br>PET and XA as supported by<br>ACR/NEMA DICOM 3.0. | MIM 4.0 (NEURO) is a<br>software package that<br>provides the physician with the<br>means to display, register and<br>fuse medical images from<br>multiple modalities. |
| | MIM provides the user with<br>the means to display, register<br>and fuse medical images from<br>multiple modalities.<br>Additionally, it evaluates<br>cardiac left ventricular<br>function and perfusion,<br>including left ventricular<br>end-diastolic volume,<br>end-systolic volume, and<br>ejection fraction. | MIM provides the user with<br>the means to display, register<br>and fuse medical images from<br>multiple modalities.<br>Additionally, it evaluates<br>cardiac left ventricular<br>function and perfusion,<br>including left ventricular<br>end-diastolic volume,<br>end-systolic volume, and<br>ejection fraction. | Additionally, it evaluates<br>cardiac left ventricular function<br>and perfusion including left<br>ventricular end-diastolic<br>volume, end-systolic volume,<br>and ejection fraction. |
| | The Region of Interest (ROI)<br>feature reduces the time<br>necessary for the user to<br>define objects in medical<br>image volumes by providing<br>an initial definition of object<br>contours. The objects include,<br>but are not limited to, tumors<br>and normal tissues.<br>MIM provides tools to quickly<br>create, transform, and modify | The Region of Interest (ROI)<br>feature reduces the time<br>necessary for the user to<br>define objects in medical<br>image volumes by providing<br>an initial definition of object<br>contours. The objects include,<br>but are not limited to, tumors<br>and normal tissues.<br>MIM provides tools to quickly<br>create, transform, and modify | The Region of Interest (ROI)<br>feature reduces the time<br>necessary for the physician to<br>define objects in medical<br>image volumes by providing<br>an initial definition of object<br>contours. The objects include<br>but are not limited to tumors<br>and organs. |
| | contours for applications<br>including, but not limited to,<br>quantitative analysis, aiding<br>adaptive therapy, transferring<br>contours to radiation therapy<br>treatment planning systems<br>and archiving contours for<br>patient follow-up and<br>management. | contours for applications<br>including, but not limited to,<br>quantitative analysis, aiding<br>adaptive therapy, transferring<br>contours to radiation therapy<br>treatment planning systems<br>and archiving contours for<br>patient follow-up and<br>management. | MIM 4.0 (NEURO) also aids<br>the physician in the<br>assessment of PET/SPECT<br>brain scans. It provides<br>automated quantitative and<br>statistical analysis by<br>automatically registering<br>PET/SPECT brain scans to a<br>standard template and<br>comparing intensity values to a<br>reference database or to other<br>PET/SPECT scans on a voxel<br>by voxel basis, within<br>stereotactic surface<br>projections, or within<br>standardized<br>regions of interest. |
| | MIM aids in the assessment<br>of PET/SPECT brain scans. It<br>provides automated<br>quantitative and statistical<br>analysis by automatically<br>registering PET/SPECT brain<br>scans to a standard template<br>and comparing intensity<br>values to a reference<br>database or to other<br>PET/SPECT scans on a<br>voxel-by-voxel basis, within<br>stereotactic surface<br>projections or standardized<br>regions of interest. | MIM aids in the assessment<br>of PET/SPECT brain scans. It<br>provides automated<br>quantitative and statistical<br>analysis by automatically<br>registering PET/SPECT brain<br>scans to a standard template<br>and comparing intensity<br>values to a reference<br>database or to other<br>PET/SPECT scans on a<br>voxel-by- voxel basis, within<br>stereotactic surface<br>projections or standardized<br>regions of interest. | |
| | MIM allows the dose<br>distribution of an implant to be<br>individually shaped for each<br>patient and is a<br>general-purpose<br>brachytherapy planning<br>system used for prospective<br>and confirmation dose<br>calculations for patients<br>undergoing a course of<br>brachytherapy using<br>permanent implants of various<br>radioisotopes (not including<br>radioactive microspheres). | MIM allows the dose<br>distribution of an implant to be<br>individually shaped for each<br>patient and is a<br>general-purpose<br>brachytherapy planning<br>system used for prospective<br>and confirmation dose<br>calculations for patients<br>undergoing a course of<br>brachytherapy using<br>permanent implants of various<br>radioisotopes (not including<br>radioactive microspheres). | |
| | MIM allows voxel-based dose<br>calculations for patients who<br>have been administered<br>radioisotopes or radioactive<br>microspheres. | MIM allows voxel-based dose<br>calculations for patients who<br>have been administered<br>radioisotopes or radioactive<br>microspheres. | |
| Indications for<br>Use | MIM software is used by<br>trained medical professionals<br>as a tool to aid in evaluation<br>and information management<br>of digital medical images. The<br>medical image modalities<br>include, but are not limited to, | MIM software is used by<br>trained medical professionals<br>as a tool to aid in evaluation<br>and information management<br>of digital medical images. The<br>medical image modalities<br>include, but are not limited to, | The MIM software program<br>should be used for the<br>registration, fusion and display<br>of medical images from<br>multi-modalities, such as<br>SPECT, PET, CT, and MRI. |
| CT, MR, CR, DX, MG, US,<br>SPECT, PET and XA as<br>supported by ACR/NEMA<br>DICOM 3.0. MIM assists in<br>the following indications: | CT, MRI, CR, DX, MG, US,<br>SPECT, PET and XA as<br>supported by ACR/NEMA<br>DICOM 3.0. MIM assists in<br>the following indications: | | |
| • Receive, transmit, store,<br>retrieve, display, print, and<br>process medical images and<br>DICOM objects. | • Receive, transmit, store,<br>retrieve, display, print, and<br>process medical images and<br>DICOM objects. | | |
| • Create, display, and print<br>reports from medical images. | • Create, display and print<br>reports from medical images. | | |
| • Registration, fusion display,<br>and review of medical images<br>for diagnosis, treatment<br>evaluation, and treatment<br>planning. | • Registration, fusion display,<br>and review of medical images<br>for diagnosis, treatment<br>evaluation, and treatment<br>planning. | | |
| • Evaluation of cardiac left<br>ventricular function and<br>perfusion, including left<br>ventricular end-diastolic<br>volume, end-systolic volume,<br>and ejection fraction. | • Evaluation of cardiac left<br>ventricular function and<br>perfusion, including left<br>ventricular end-diastolic<br>volume, end-systolic volume,<br>and ejection fraction. | | |
| • Localization and definition of<br>objects such as tumors and<br>normal tissues in medical<br>images. | • Localization and definition of<br>objects such as tumors and<br>normal tissues in medical<br>images. | MIM assists in definition of<br>structures in medical images<br>including tumors, organs, and<br>cardiac left ventricular cavity. | |
| • Creation, transformation,<br>and modification of contours<br>for applications including, but<br>not limited to, quantitative<br>analysis, aiding adaptive<br>therapy, transferring contours<br>to radiation therapy treatment<br>planning systems, and<br>archiving contours for patient<br>follow-up and management. | • Creation, transformation,<br>and modification of contours<br>for applications including, but<br>not limited to, quantitative<br>analysis, aiding adaptive<br>therapy, transferring contours<br>to radiation therapy treatment<br>planning systems, and<br>archiving contours for patient<br>follow-up and management. | | |
| • Quantitative and statistical<br>analysis of PET/SPECT brain<br>scans by comparing to other<br>registered PET/SPECT brain<br>scans. | • Quantitative and statistical<br>analysis of PET/SPECT brain<br>scans by comparing to other<br>registered PET/SPECT brain<br>scans. | MIM aids in the assessment of<br>PET/SPECT brain scans by<br>providing quantitative and<br>statistical comparisons to other<br>registered PET/SPECT brain<br>scans. | |
| • Planning and evaluation of<br>permanent implant<br>brachytherapy procedures<br>(not including radioactive<br>microspheres). | • Planning and evaluation of<br>permanent implant<br>brachytherapy procedures<br>(not including radioactive<br>microspheres). | | |
| | • Calculating absorbed<br>radiation dose as a result of<br>administering a radionuclide. | • Calculating absorbed<br>radiation dose as a result of<br>administering a radionuclide. | • Calculating absorbed<br>radiation dose as a result of<br>administering a radionuclide. |
| | When using the device<br>clinically, within the United<br>States, the user should only<br>use FDA approved<br>radiopharmaceuticals. If used<br>with unapproved ones, this<br>device should only be used<br>for research purposes. | When using this device<br>clinically within the United<br>States, the user should only<br>use FDA-approved<br>radiopharmaceuticals. If used<br>with unapproved ones, this<br>device should only be used<br>for research purposes. | When using this device<br>clinically within the United<br>States, the user should only<br>use FDA-approved<br>radiopharmaceuticals. If used<br>with unapproved ones, this<br>device should only be used<br>for research purposes. |
| | Lossy compressed<br>mammographic images and<br>digitized film screen images<br>must not be reviewed for<br>primary image interpretations.<br>Images that are printed to film<br>must be printed using a<br>FDA-approved printer for the<br>diagnosis of digital<br>mammography images.<br>Mammographic images must<br>be viewed on a display<br>system that has been cleared<br>by the FDA for the diagnosis<br>of digital mammography<br>images. The software is not to<br>be used for mammography<br>CAD. | Lossy compressed<br>mammographic images and<br>digitized film screen images<br>must not be reviewed for<br>primary image interpretations.<br>Images that are printed to film<br>must be printed using a<br>FDA-approved printer for the<br>diagnosis of digital<br>mammography images.<br>Mammographic images must<br>be viewed on a display<br>system that has been cleared<br>by the FDA for the diagnosis<br>of digital mammography<br>images. The software is not to<br>be used for mammography<br>CAD. | Lossy compressed<br>mammographic images and<br>digitized film screen images<br>must not be reviewed for<br>primary image interpretations.<br>Images that are printed to film<br>must be printed using a<br>FDA-approved printer for the<br>diagnosis of digital<br>mammography images.<br>Mammographic images must<br>be viewed on a display<br>system that has been cleared<br>by the FDA for the diagnosis<br>of digital mammography<br>images. The software is not to<br>be used for mammography<br>CAD. |
| Operating<br>Platform | Microsoft Windows, Apple®<br>OS X, Linux-based OS | Microsoft Windows, Apple®<br>OS X, Linux-based OS | Microsoft Windows |
| Supported<br>Imaging<br>Modalities | CT, MR, CR, DX, MG, US,<br>NM, PET, XA, and other<br>DICOM modalities | CT, MR, CR, DX, MG, US,<br>NM, PET, XA, and other<br>DICOM modalities | CT, MR, NM, PET, OT, and<br>other DICOM modalities |
| Receive,<br>transmit,<br>display, general<br>manipulation<br>(window/level,<br>pan, zoom,<br>cross-hairs,<br>slice<br>navigation),<br>and<br>co-registration<br>of medical<br>images | Yes | Yes | Yes |
| Radiopharmac<br>eutical-specific<br>template | Yes, unchanged from MIM –<br><i>Additional Tracers</i> (K223800) | Yes | Yes |
| registration | | | |
| Amyloid PET<br>Quantification | Voxel-based z-scores,<br>regional z-scores, regional<br>SUVr, global SUVr,<br>Centiloid scaling | Voxel-based z-scores,<br>regional z-scores, regional<br>SUVr, global SUVr | Voxel-based z-scores, regional<br>z-scores, regional SUVr, global<br>SUVr |

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Image /page/7/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" underneath in a smaller font. The logo is simple and modern, with a focus on the company's name.

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Image /page/8/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle in the intersection. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it.

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Image /page/9/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, with a focus on the company's name.

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Image /page/10/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle in the middle. To the right of the squares is the text "mim" in black, with the wo…