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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and a study proving the device meets those criteria, specifically for the "MIM - Additional Tracers" software (K223800). The key information is extracted below.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list numerical acceptance criteria. Instead, it describes a validation process focused on the accuracy of template registration and quantitative analysis for the newly supported PET/SPECT tracers. The "reported device performance" is a qualitative statement of approval by experts.

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Accurate template registration for each tracer (Amyvid™, Vizamyl™, Neuraceq™, DaTscan™) and corresponding clinical use case.	Assessed and approved by a radiologist and MIM technical experts. Risk mitigation for automatic registration error is built-in with adjustment and verification steps.
Accurate placement of reference and analysis regions (specifically for DaTscan™).	Verified with built-in affine registration to the template and individual hemisphere verification and adjustment.
Creation of accurate normal patient 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 inclusion.
Quantitative analysis results on representative population scans align with expert reads.	Compared to expert reads and reviewed by physicians and MIM technical experts. Discrepancies only acceptable for misregistered, borderline, or poor-quality scans.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: "Normal patient scans were curated to span demographics appropriate for each tracer." The exact number of scans is not specified.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied that these are existing patient scans curated for the purpose of creating normal databases and performing quantitative analysis.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: A "radiologist" (singular) and "MIM technical experts" (plural) were involved. The exact number of MIM technical experts is not specified.
Qualifications: "Radiologist" and "MIM technical experts" are provided as qualifications. No specific experience levels (e.g., "10 years of experience") are given for the radiologist.

4. Adjudication Method for the Test Set

The adjudication method appears to be a consensus-based approach with expert review and approval. For template registration accuracy, a radiologist and MIM technical experts assessed and approved. For normal patient database creation, the same group approved. For quantitative analysis, results were compared to expert reads and reviewed by physicians and MIM technical experts. Discrepancies were noted and deemed acceptable only under specific conditions (misregistered, borderline, or poor-quality scans). This suggests a process where expert input directly defines or validates the acceptable outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The study described focuses on the standalone performance of the software with expert review, not on human readers' improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The description indicates that the software's template registration accuracy and quantitative analysis results were assessed by experts. The "risk mitigation for automatic registration error" built into the software, which includes "registration adjustment and verification steps" by the user, implies a workflow involving a human in the loop. However, the initial assessment and comparison of quantitative results to expert reads suggest an evaluation of the algorithm's output independently, even if human verification is part of the clinical workflow.

7. Type of Ground Truth Used

The ground truth was established through expert consensus/reads. For template registration and contour accuracy, a radiologist and MIM technical experts approved the alignment and contours. For quantitative analysis, results were compared to "expert reads" and reviewed by physicians and MIM technical experts.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. The description focuses on creating "normal patient scans...curated to span demographics appropriate for each tracer" which were then aligned to template space to create "databases for each tracer." These databases could be considered analogous to a reference/training set for the software's internal operations or for comparison, but it's not explicitly labeled as such for a machine learning model.

9. How the Ground Truth for the Training Set Was Established

If the "normal patient scans" and "databases for each tracer" are considered part of a training or reference set, then their ground truth was established by:

Expert Approval: "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."

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

· 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.

· 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: 216-455-0600 Fax: 216-455-0601

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

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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.

• 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.

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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 operates on Windows, Mac, and Linux computer systems.

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).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

ITEM	MIM - ADDITIONALTRACERS(K# - TBD)	MIM ON LINUX(K190379)	MIM 4.0 NEURO(K060816)
ClearanceDates	TBD	March 19, 2019	March 24, 2006
IntendedUse	MIM software is intended fortrained medical professionalsincluding, but not limited to,radiologists, oncologists,physicians, medicaltechnologists, dosimetrists,and physicists.MIM is a medical image andinformation managementsystem that is intended toreceive, transmit, store,retrieve, display, print andprocess digital medicalimages, as well as create,display, and print reports fromthose images. The medicalmodalities of these medicalimaging systems include, but	MIM software is intended fortrained medical professionalsincluding, but not limited to,radiologists, oncologists,physicians, medicaltechnologists, dosimetrists,and physicists.MIM is a medical image andinformation managementsystem that is intended toreceive, transmit, store,retrieve, display, print andprocess digital medicalimages, as well as create,display, and print reports fromthose images. The medicalmodalities of these medicalimaging systems include, but	MIM 4.0 (NEURO) is asoftware package thatprovides the physicianwith the means todisplay, register andfuse medical imagesfrom multiplemodalities. Additionally,it evaluates cardiac leftventricular function andperfusion including leftventricular end-diastolicvolume, end-systolicvolume, and ejectionfraction. The Region ofinterest (ROI) featurereduces the timenecessary for thephysician to defineobjects in medical
ITEM	MIM - ADDITIONALTRACERS(K# - TBD)	MIM ON LINUX(K190379)	MIM 4.0 NEURO(K060816)
	CR, DX, MG, US, SPECT,PET and XA as supported byACR/NEMA DICOM 3.0.	CR, DX, MG, US, SPECT,PET and XA as supported byACR/NEMA DICOM 3.0.	image volumes byproviding an initialdefinition of objectcontours. The objectsinclude but are notlimited to tumors andorgans.
	MIM provides the user with themeans to display, register andfuse medical images frommultiple modalities.Additionally, it evaluatescardiac left ventricular functionand perfusion, including leftventricular end-diastolicvolume, end-systolic volume,and ejection fraction. TheRegion of Interest (ROI)feature reduces the timenecessary for the user todefine objects in medicalimage volumes by providingan initial definition of objectcontours. The objects include,but are not limited to, tumorsand normal tissues.	MIM provides the user with themeans to display, register andfuse medical images frommultiple modalities.Additionally, it evaluatescardiac left ventricular functionand perfusion, including leftventricular end-diastolicvolume, end-systolic volume,and ejection fraction. TheRegion of Interest (ROI)feature reduces the timenecessary for the user todefine objects in medicalimage volumes by providingan initial definition of objectcontours. The objects include,but are not limited to, tumorsand normal tissues.	MIM 4.0 (NEURO) alsoaids the physician inthe assessment ofPET/SPECT brainscans. It providesautomated quantitativeand statistical analysisby automaticallyregistering PET/SPECTbrain scans to astandard template andcomparing intensityvalues to a referencedatabase or to otherPET/SPECT scans on
	MIM provides tools to quicklycreate, transform, and modifycontours for applicationsincluding, but not limited to,quantitative analysis, aidingadaptive therapy, transferringcontours to radiation therapytreatment planning systemsand archiving contours forpatient follow-up andmanagement.	MIM provides tools to quicklycreate, transform, and modifycontours for applicationsincluding, but not limited to,quantitative analysis, aidingadaptive therapy, transferringcontours to radiation therapytreatment planning systemsand archiving contours forpatient follow-up andmanagement.	a voxel-by-voxel basis,within stereotacticsurface projections, orwithin standardizedregions of interest"
	MIM aids in the assessmentof PET/SPECT brain scans. Itprovides automatedquantitative and statisticalanalysis by automaticallyregistering PET/SPECT brainscans to a standard templateand comparing intensity valuesto a reference database or toother PET/SPECT scans on avoxel-by-voxel basis, within	MIM aids in the assessmentof PET/SPECT brain scans. Itprovides automatedquantitative and statisticalanalysis by automaticallyregistering PET/SPECT brainscans to a standard templateand comparing intensity valuesto a reference database or toother PET/SPECT scans on avoxel-by-voxel basis, within
ITEM	MIM - ADDITIONALTRACERS(K# - TBD)	MIM ON LINUX(K190379)	MIM 4.0 NEURO(K060816)
	stereotactic surfaceprojections or standardizedregions of interest.	stereotactic surfaceprojections or standardizedregions of interest.	stereotactic surfaceprojections or standardizedregions of interest.
	MIM allows the dosedistribution of an implant to beindividually shaped for eachpatient and is a general-purpose brachytherapyplanning system used forprospective and confirmationdose calculations for patientsundergoing a course ofbrachytherapy usingpermanent implants of variousradioisotopes (not includingradioactive microspheres).	MIM allows the dosedistribution of an implant to beindividually shaped for eachpatient and is a general-purpose brachytherapyplanning system used forprospective and confirmationdose calculations for patientsundergoing a course ofbrachytherapy usingpermanent implants of variousradioisotopes (not includingradioactive microspheres).	MIM allows the dosedistribution of an implant to beindividually shaped for eachpatient and is a general-purpose brachytherapyplanning system used forprospective and confirmationdose calculations for patientsundergoing a course ofbrachytherapy usingpermanent implants of variousradioisotopes (not includingradioactive microspheres).
	MIM allows voxel-based dosecalculations for patients whohave been administeredradioisotopes or radioactivemicrospheres.	MIM allows voxel-based dosecalculations for patients whohave been administeredradioisotopes or radioactivemicrospheres.	MIM allows voxel-based dosecalculations for patients whohave been administeredradioisotopes or radioactivemicrospheres.
Indicationsfor Use	MIM software is used bytrained medical professionalsas a tool to aid in evaluationand information managementof digital medical images. Themedical image modalitiesinclude, but are not limited to,CT, MRI, CR, DX, MG, US,SPECT, PET and XA assupported by ACR/NEMADICOM 3.0. MIM assists in thefollowing indications:• Receive, transmit, store,	MIM software is used bytrained medical professionalsas a tool to aid in evaluationand information managementof digital medical images. Themedical image modalitiesinclude, but are not limited to,CT, MRI, CR, DX, MG, US,SPECT, PET and XA assupported by ACR/NEMADICOM 3.0. MIM assists in thefollowing indications:• Receive, transmit, store,	The MIM softwareprogram should beused for theregistration, fusion anddisplay ofmedical images frommulti-modalities, suchas SPECT, PET, CT,and MRI. MIM assistsin definition ofstructures in medicalimages includingtumors, organs, andcardiac left
	retrieve, display, print, andprocess medical images andDICOM objects.• Create, display and printreports from medical images.	retrieve, display, print, andprocess medical images andDICOM objects.• Create, display and printreports from medical images.	ventricular cavity. MIMaids in the assessmentof PET/SPECT brainscans by providingquantitative andstatistical comparisonsto other registered
ITEM	MIM - ADDITIONALTRACERS(K# - TBD)	MIM ON LINUX(K190379)	MIM 4.0 NEURO(K060816)
	• Registration, fusion display,and review of medical imagesfor diagnosis, treatmentevaluation, and treatmentplanning.	• Registration, fusion display,and review of medical imagesfor diagnosis, treatmentevaluation, and treatmentplanning.	PET/SPECT brainscans.
	• Evaluation of cardiac leftventricular function andperfusion, including leftventricular end-diastolicvolume, end-systolic volume,and ejection fraction.	• Evaluation of cardiac leftventricular function andperfusion, including leftventricular end-diastolicvolume, end-systolic volume,and ejection fraction.
	• Localization and definition ofobjects such as tumors andnormal tissues in medicalimages.	• Localization and definition ofobjects such as tumors andnormal tissues in medicalimages.
	• Creation, transformation, andmodification of contours forapplications including, but notlimited to, quantitativeanalysis, aiding adaptivetherapy, transferring contoursto radiation therapy treatmentplanning systems, andarchiving contours for patientfollow-up and management.	• Creation, transformation, andmodification of contours forapplications including, but notlimited to, quantitativeanalysis, aiding adaptivetherapy, transferring contoursto radiation therapy treatmentplanning systems, andarchiving contours for patientfollow-up and management.
	• Quantitative and statisticalanalysis of PET/SPECT brainscans by comparing to otherregistered PET/SPECT brainscans.	• Quantitative and statisticalanalysis of PET/SPECT brainscans by comparing to otherregistered PET/SPECT brainscans.
	• Planning and evaluation ofpermanent implantbrachytherapy procedures(not including radioactivemicrospheres).	• Planning and evaluation ofpermanent implantbrachytherapy procedures(Not including radioactivemicrospheres).
	• Calculating absorbedradiation dose as a result ofadministering a radionuclide.	• Calculating absorbedradiation dose as a result ofadministering a radionuclide.
	When using this deviceclinically within the United	When using device clinically,the user should only use FDA
ITEM	MIM - ADDITIONALTRACERS(K# - TBD)	MIM ON LINUX(K190379)	MIM 4.0 NEURO(K060816)
	States, the user should onlyuse FDA-approvedradiopharmaceuticals. If usedwith unapproved ones, thisdevice should only be used forresearch purposes.	approvedradiopharmaceuticals. If usingwith unapproved ones, thisdevice should only be used forresearch purposes.
	Lossy compressedmammographic images anddigitized film screen imagesmust not be reviewed forprimary image interpretations.Images that are printed to filmmust be printed using a FDA-approved printer for thediagnosis of digitalmammography images.Mammographic images mustbe viewed on a display systemthat has been cleared by theFDA for the diagnosis of digitalmammography images. Thesoftware is not to be used formammography CAD.	Lossy compressedmammographic images anddigitized film screen imagesmust not be reviewed forprimary image interpretations.Images that are printed to filmmust be printed using a FDA-approved printer for thediagnosis of digitalmammography images.Mammographic images mustbe viewed on a display systemthat has been cleared by theFDA for the diagnosis of digitalmammography images. Thesoftware is not to be used formammography CAD.
Receive,Transmit,Retrieve,Display,Print DigitalMedicalImages	Yes	Yes	Yes
MIMworkstationfeaturesandfunctionality	Yes	Yes	Yes
OperatingPlatform	Microsoft Windows,Apple® OSLinux-based OS	Microsoft Windows,Apple® OSLinux-based OS	Microsoft Windows,Apple® OS
TracerSupport	PET• FDG• Amyvid™• (Florbetapir),	PET• FDGSPECT• HMPAO	PET• FDGSPECT• HMPAO
ITEM	MIM - ADDITIONALTRACERS(K# - TBD)	MIM ON LINUX(K190379)	MIM 4.0 NEURO(K060816)
	Vizamyl™(Flutemetamol) Neuraceq™(Florbetaben)
	SPECT HMPAO DaTscan™ (Ioflupane)