MIM – Additional Tracers

K223800 · Mim Software, Inc. · LLZ · Jan 17, 2023 · Radiology

Device Facts

• Record ID: K223800
• Device Name: MIM – Additional Tracers
• Applicant: Mim Software, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 17, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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

Device Story

MIM - Additional Tracers is a software-only expansion of the existing MIM - On Linux platform. It functions as a medical image management and processing system. The device ingests DICOM-compliant medical images (CT, MRI, PET, SPECT, etc.). It performs automated registration of PET/SPECT brain scans to standard templates and compares intensity values against a reference database or other scans on a voxel-by-voxel basis. The software provides tools for clinicians (radiologists, oncologists, etc.) to perform image fusion, contouring, and quantitative analysis. Outputs include processed images, statistical reports, and dose calculations for brachytherapy. The device is used in clinical settings to assist in diagnosis, treatment evaluation, and radiation therapy planning. By automating registration and providing quantitative comparisons, it aims to improve the efficiency and accuracy of clinical assessments. The software operates on Windows, Mac, and Linux systems.

Clinical Evidence

Bench testing only. Accuracy of template registration and quantitative analysis for new tracers (Amyvid, Vizamyl, Neuraceq, DaTscan) was validated by radiologists and technical experts. Normal patient scans were curated to create tracer-specific databases. Registration accuracy was verified through visual inspection and manual adjustment tools. Quantitative results were compared against expert reads to ensure clinical validity.

Technological Characteristics

Software-based medical image management and processing system. Operates on Windows, Mac, and Linux. Supports ACR/NEMA DICOM 3.0 standards. Features include automated image registration, fusion, contouring, and quantitative analysis. No hardware components. Algorithm class: rule-based and automated registration/statistical analysis.

Indications for Use

Indicated for trained medical professionals to aid in evaluation and information management of digital medical images (CT, MRI, CR, DX, MG, US, SPECT, PET, XA). Assists in image processing, reporting, registration/fusion, cardiac LV function/perfusion analysis, tumor/tissue contouring, PET/SPECT brain scan quantitative/statistical analysis, brachytherapy planning, and radiation dose calculation. Not for mammography CAD. Lossy compressed mammographic images/digitized film screen images must not be used for primary interpretation.

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 - On Linux (K190379)

Reference Devices

• MIM 4.0 (NEURO) (K060816)

Submission Summary (Full Text)

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January 17, 2023

MIM Software Inc. % Megan Fontanez Clinical Science Team Lead 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122

Re: K223800

Trade/Device Name: MIM - Additional Tracers Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: December 16, 2022 Received: December 19, 2022

Dear Megan Fontanez:

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 (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 located 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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

D. G. K.

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team 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

Enclosure

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## Indications for Use

510(k) Number (if known) K223800

Device Name MIM - Additional Tracers

#### 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, 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/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 where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the word "SOFTWARE" in a smaller, sans-serif font, followed by the registered trademark symbol.

### K223800

### 510(k) Summary of Safety and Effectiveness

(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: [phone] Fax: [phone]

Contact Person: Date Summary Prepared: Megan Fontanez December 16, 2022

### Device Name

Trade Name: MIM – Additional Tracers Common Name: Medical Imaging Software Regulation Number / Product Code: 21 CFR 892.2050 / Product Code LLZ Classification Name: System, Imaging Processing, Radiological

#### Predicate Device

K190379

MIM — On Linux

### Reference Device

K060816

MIM 4.0 (NEURO)

MIMvista Corp.

MIM Software Inc.

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Image /page/5/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping 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, and the colors are eye-catching.

### Intended Use

MIM software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists, and physicists, 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, MRI, 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 Reqion 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-byvoxel 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 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:

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Image /page/6/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 in the red square. To the right of the squares is the text "mim SOFTWARE" in black. The word "mim" is in a larger font than the word "SOFTWARE".

• 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 reqistered 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 FDAapproved 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.

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Image /page/7/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 center. To the right of the squares is the text "mim" in black, with the word "SOFTWARE" in smaller black letters below it. The logo is simple and modern, and the colors are eye-catching.

### Device Description

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.

| ITEM | MIM - ADDITIONAL<br>TRACERS<br>(K# - TBD) | MIM ON LINUX<br>(K190379) | MIM 4.0 NEURO<br>(K060816) |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clearance<br>Dates | TBD | March 19, 2019 | March 24, 2006 |
| Intended<br>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 | 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 | MIM 4.0 (NEURO) is a<br>software package that<br>provides the physician<br>with the means to<br>display, register and<br>fuse medical images<br>from multiple<br>modalities. Additionally,<br>it evaluates cardiac left<br>ventricular function and<br>perfusion including left<br>ventricular end-diastolic<br>volume, end-systolic<br>volume, and ejection<br>fraction. The Region of<br>interest (ROI) feature<br>reduces the time<br>necessary for the<br>physician to define<br>objects in medical |
| ITEM | MIM - ADDITIONAL<br>TRACERS<br>(K# - TBD) | MIM ON LINUX<br>(K190379) | MIM 4.0 NEURO<br>(K060816) |
| | CR, DX, MG, US, SPECT,<br>PET and XA as supported by<br>ACR/NEMA DICOM 3.0. | CR, DX, MG, US, SPECT,<br>PET and XA as supported by<br>ACR/NEMA DICOM 3.0. | image volumes by<br>providing an initial<br>definition of object<br>contours. The objects<br>include but are not<br>limited to tumors and<br>organs. |
| | MIM provides the user with the<br>means to display, register and<br>fuse medical images from<br>multiple modalities.<br>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<br>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. | MIM provides the user with the<br>means to display, register and<br>fuse medical images from<br>multiple modalities.<br>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<br>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. | MIM 4.0 (NEURO) also<br>aids the physician in<br>the assessment of<br>PET/SPECT brain<br>scans. It provides<br>automated quantitative<br>and statistical analysis<br>by automatically<br>registering PET/SPECT<br>brain scans to a<br>standard template and<br>comparing intensity<br>values to a reference<br>database or to other<br>PET/SPECT scans on |
| | MIM provides tools to quickly<br>create, transform, and modify<br>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 provides tools to quickly<br>create, transform, and modify<br>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. | a voxel-by-voxel basis,<br>within stereotactic<br>surface projections, or<br>within 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 values<br>to a reference database or to<br>other PET/SPECT scans on a<br>voxel-by-voxel basis, within | 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 values<br>to a reference database or to<br>other PET/SPECT scans on a<br>voxel-by-voxel basis, within | |
| ITEM | MIM - ADDITIONAL<br>TRACERS<br>(K# - TBD) | MIM ON LINUX<br>(K190379) | MIM 4.0 NEURO<br>(K060816) |
| | stereotactic surface<br>projections or standardized<br>regions of interest. | stereotactic surface<br>projections or standardized<br>regions of interest. | 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 general-<br>purpose brachytherapy<br>planning system used for<br>prospective and confirmation<br>dose 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 general-<br>purpose brachytherapy<br>planning system used for<br>prospective and confirmation<br>dose 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 general-<br>purpose brachytherapy<br>planning system used for<br>prospective and confirmation<br>dose 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. | MIM allows voxel-based dose<br>calculations for patients who<br>have been administered<br>radioisotopes or radioactive<br>microspheres. |
| Indications<br>for 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,<br>CT, MRI, CR, DX, MG, US,<br>SPECT, PET and XA as<br>supported by ACR/NEMA<br>DICOM 3.0. MIM assists in the<br>following indications:<br>• Receive, transmit, store, | 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,<br>CT, MRI, CR, DX, MG, US,<br>SPECT, PET and XA as<br>supported by ACR/NEMA<br>DICOM 3.0. MIM assists in the<br>following indications:<br>• Receive, transmit, store, | The MIM software<br>program should be<br>used for the<br>registration, fusion and<br>display of<br>medical images from<br>multi-modalities, such<br>as SPECT, PET, CT,<br>and MRI. MIM assists<br>in definition of<br>structures in medical<br>images including<br>tumors, organs, and<br>cardiac left |
| | retrieve, display, print, and<br>process medical images and<br>DICOM objects.<br>• Create, display and print<br>reports from medical images. | retrieve, display, print, and<br>process medical images and<br>DICOM objects.<br>• Create, display and print<br>reports from medical images. | ventricular cavity. MIM<br>aids in the assessment<br>of PET/SPECT brain<br>scans by providing<br>quantitative and<br>statistical comparisons<br>to other registered |
| ITEM | MIM - ADDITIONAL<br>TRACERS<br>(K# - TBD) | MIM ON LINUX<br>(K190379) | MIM 4.0 NEURO<br>(K060816) |
| | • 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. | PET/SPECT brain<br>scans. |
| | • 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. | |
| | • Creation, transformation, and<br>modification of contours for<br>applications including, but not<br>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, and<br>modification of contours for<br>applications including, but not<br>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. | |
| | • 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. | |
| | When using this device<br>clinically within the United | When using device clinically,<br>the user should only use FDA | |
| ITEM | MIM - ADDITIONAL<br>TRACERS<br>(K# - TBD) | MIM ON LINUX<br>(K190379) | MIM 4.0 NEURO<br>(K060816) |
| | States, the user should only<br>use FDA-approved<br>radiopharmaceuticals. If used<br>with unapproved ones, this<br>device should only be used for<br>research purposes. | approved<br>radiopharmaceuticals. If using<br>with unapproved ones, this<br>device should only be used for<br>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 FDA-<br>approved printer for the<br>diagnosis of digital<br>mammography images.<br>Mammographic images must<br>be viewed on a display system<br>that has been cleared by the<br>FDA for the diagnosis of digital<br>mammography images. The<br>software is not to be used for<br>mammography 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 FDA-<br>approved printer for the<br>diagnosis of digital<br>mammography images.<br>Mammographic images must<br>be viewed on a display system<br>that has been cleared by the<br>FDA for the diagnosis of digital<br>mammography images. The<br>software is not to be used for<br>mammography CAD. | |
| Receive,<br>Transmit,<br>Retrieve,<br>Display,<br>Print Digital<br>Medical<br>Images | Yes | Yes | Yes |
| MIM<br>workstation<br>features<br>and<br>functionality | Yes | Yes | Yes |
| Operating<br>Platform | Microsoft Windows,<br>Apple® OS<br>Linux-based OS | Microsoft Windows,<br>Apple® OS<br>Linux-based OS | Microsoft Windows,<br>Apple® OS |
| Tracer<br>Support | PET<br>• FDG<br>• Amyvid™<br>• (Florbetapir), | PET<br>• FDG<br>SPECT<br>• HMPAO | PET<br>• FDG<br>SPECT<br>• HMPAO |
| ITEM | MIM - ADDITIONAL<br>TRACERS<br>(K# - TBD) | MIM ON LINUX<br>(K190379) | MIM 4.0 NEURO<br>(K060816) |
| | Vizamyl™<br>(Flutemetamol) Neuraceq™<br>(Florbetaben) | | |
| | SPECT HMPAO DaTscan™ (Ioflupane) | | |

# Substantial Equivalence

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Image /page/8/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.

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Image /page/9/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim SOFTWARE" in black. The letters "mim" are in a larger, bolder font than the word "SOFTWARE".

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Image /page/10/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, and the colors are eye-catching.

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Image /page/11/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, on the left side of the logo. To the right of the squares is the text "mim SOFTWARE" in black font. The word "mim" is in a larger font than the word "SOFTWARE".

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Image /page/12/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.

### Discussion

MIM - Additional Tracers is substantially equivalent to past MIM software 510(k) clearances. MIM - on Linux was chosen as the predicate device to represent the broad range of indications for use and intended uses that encompasses MIM software. The comparison chart above shows that the only difference within this catch-up special 510(k) is the additional tracer support.

### Testing and Performance Data

Template registration accuracy for each tracer and corresponding clinical use case was assessed by a radiologist and MIM technical experts. Risk mitigation for automatic registration error is built-in to the software with registration adjustment and verification steps. For amyloid PET registration, the user inspects and adjusts affine registration to template space with displayed fusions to an amyloid positive, amyloid negative, and mean template. There is a secondary verification step to confirm registration accuracy as well. For DaTscan registration, there is built-in affine registration to the template and individual hemisphere verification and adjustment to ensure accurate placement of the reference and analysis regions.

Normal patient scans were curated to span demographics appropriate for each tracer. After selection, these series were then aligned to template space to create databases for each tracer. Alignment to template space and accuracy of analysis contours for each tracer were approved by a radiologist and MIM technical experts before each series could be included in the normals database.

Quantitative analysis results on a selection of scans representative of the population for each tracer were compared to expert reads and reviewed by physicians and MIM technical experts. Discrepancies were only acceptable for misregistered, borderline, or poor-quality scans.

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Image /page/13/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping 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 simple color palette.

## Conclusion

Based on the Discussion and Testing and Performance Data, the proposed device is determined to be as safe and effective as its predicate device, K190379 (MIM – On Linux), and its reference device, K060816 (MIM 4.0 Neuro).