MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:

Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
Create, display, and print reports from medical images.
Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
Localization and definition of objects such as tumors and normal tissues in medical images.
Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
Calculating absorbed radiation dose as a result of administering a radionuclide.
Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.

When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

Device Description

MIM – Dose Analysis extends features of MIM – Ablation (K220256). It is designed for use in medical imaging and operates on both Windows and Mac computer systems. MIM - Dose Analysis is a standalone software application that provides:

Calculation of Biologically Effective Dose (BED) and Equieffective Dose in specified fractions (e.g., EQD2)
Evaluation of radiation dose on different image sets through the use of rigid and deformable registration objects
Accumulation of doses

AI/ML Overview

The provided text describes the regulatory clearance of "MIM - Dose Analysis" software. While it outlines the device's functionality and states that testing was performed, it does not provide explicit acceptance criteria in a quantitative table or the detailed study results needed to prove those criteria were met. Instead, it offers broad statements about the testing methodology and validation.

However, based on the provided text, we can infer the acceptance criteria and reconstruct what the study aimed to prove, along with the limited information available regarding the study itself.

Inferred Acceptance Criteria and Reported Device Performance

Given the nature of the device (calculating radiation dose and accumulating doses) and the statements in the "Testing and Performance Data" section, the acceptance criteria would revolve around the accuracy and consistency of these calculations.

Table 1: Inferred Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from text)	Reported Device Performance (as stated in text)
BED, EQD, and TCP Calculations: The calculated Biologically Effective Dose (BED), Equieffective Dose (EQD2), and Tumor Control Probability (TCP) by the MIM software must be accurate and fall within acceptable clinical limits when compared to manual calculations using standard equations referenced in literature. (Implicitly, this implies numerical agreement within a defined tolerance, though no specific tolerance is provided.)	"All test results yielded dose and TCP results within acceptable clinical limits when compared to manual calculations." (No specific numerical deviation or clinical limits are defined in the text.)
Dose Accumulation: The accumulated radiation dose calculated by the MIM software, especially when involving rigid and deformable registration objects across separate treatment timepoints and within physician-contoured anatomical structures, must be consistent and accurate when compared to manual dose accumulation calculations. (Implicitly, this implies numerical agreement within a defined tolerance for accumulated dose values within ROIs.)	"These test results showed consistent and accurate dose accumulation methods applied in MIM." (No specific numerical deviation or criteria for "consistent and accurate" are defined in the text.)
Overall Clinical Adequacy & Alignment: The software's performance must validate its adequacy for clinical use and demonstrate alignment with standardized equations found in literature and behavior of previously FDA-cleared software that performs similar functions (RaySearch RayStation 12A and Radformation ClearCheck).	"Altogether, the testing performed validates the adequacy of MIM - Dose Analysis for clinical use and verifies alignment between MIM software, standardized equations referenced in literature, and previously FDA-cleared softwares." (This is a high-level conclusion rather than specific performance metrics.)

Study Details from the Provided Text:

Unfortunately, the provided document is a 510(k) summary for regulatory clearance and does not contain the extensive detail of a full clinical study report. Therefore, many of the requested details are not explicitly stated.

1. Sample sized used for the test set and the data provenance:
* Sample Size: Not specified. The text mentions "Several different applications of the standard Linear-Quadratic (LQ) BED Model were tested" and "radiation doses delivered at separate timepoints for each patient dataset." This implies a case-based testing approach, but the number of cases is not provided.
* Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective data. The use of "patient datasets" could imply retrospective patient data, but this is not explicitly stated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not specified. The ground truth for BED, EQD, and TCP calculations was established by "manual calculations using the same equations referenced in literature." For dose accumulation, it was compared against "manual dose accumulation calculations" and involved "physician-contoured anatomical structures." This suggests expert involvement in contouring, but the number or qualifications of these physicians are not detailed.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not specified. The testing described primarily compares algorithmic output against manual calculations or established formulas, not against a human reader's interpretation that would require adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No MRMC or comparative effectiveness study involving human readers is mentioned or described. The study focuses on the software's calculation accuracy in a standalone manner.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, implicitly. The testing described ("BED, EQD, and TCP calculations implemented in MIM were compared against manual calculations" and "Accumulated dose was calculated in MIM... and these dose results were compared against manual dose accumulation calculations") is a standalone performance assessment of the algorithm against a defined ground truth (manual calculations/literature equations).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Calculated Ground Truth / Standardized Equations: For BED, EQD, and TCP, the ground truth was derived from "manual calculations using the same equations referenced in literature."
* Manual Calculation/Physician Contours: For dose accumulation, the ground truth was derived from "manual dose accumulation calculations" applied to "physician-contoured anatomical structures of interest."

7. The sample size for the training set:
* Not specified. This document only describes verification and validation testing, not the training of a potential machine learning model. If this software does not contain machine learning components, then "training set" is not applicable. The text does not indicate the presence of AI/ML components beyond standard imaging processing and calculation functionalities.

8. How the ground truth for the training set was established:
* Not applicable, as a training set or its ground truth establishment are not mentioned for this device in the provided text.

Summary

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May 6, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle, while the FDA part of the logo features the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

MIM Software Inc. % Sydney Lindner Clinical Engineer 25800 Science Park Drive Suite 180 CLEVLAND, OH 44122

Re: K232514

Trade/Device Name: MIM - Dose Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: August 16, 2023 Received: August 18, 2023

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/cdrb/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).

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

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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 medical devices and radiation-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,

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy 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

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Indications for Use

Submission Number (if known)

K232514

Device Name

MIM - Dose Analysis

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-diastolic volume, end-systolic volume, and ejection fraction.
· Localization and definition of objects such as tumors and normal tissues in medical images.
· Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
· Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
· Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
· Calculating absorbed radiation dose as a result of administering a radionuclide.
Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.

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 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)

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 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 clean lines and geometric shapes.

K232514

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 5, 2024

Device Name

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

Predicate and Reference Devices

Predicate:K220256	MIM – Ablation	MIM Software Inc.
References:K222312	RayStation 12A	RaySearch Laboratories AB
K220583	ClearCheck	Radformation, Inc.

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Image /page/5/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.

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, 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. MIM assists with the planning and evaluation of ablation procedures by allowing the energy zone that comprises the ablation zone to be

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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 bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a focus on the company's name.

visualized on medical imaging through the placement of virtual ablation devices for the purpose of confirming ablation zone placement.

Indications for Use

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. ●

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Image /page/7/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. Below the text "mim" is the word "SOFTWARE" in a smaller, sans-serif font, followed by a trademark symbol.

Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.
When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes.

ITEM	Subject Device:MIM -Dose Analysis(K232514)	Predicate Device:MIM -Ablation(K220256)	Reference Device:RaySearchRayStation 12A(K222312)	Reference Device:RadformationClearCheck(K220583)
Clearance Date	TBD	October 7, 2022	March 29, 2023	August 23, 2022
Intended Use	MIM software isintended for trainedmedical professionalsincluding, but notlimited to,radiologists,oncologists,physicians, medicaltechnologists,dosimetrists, andphysicists.MIM is a medicalimage and informationmanagement systemthat is intended toreceive, transmit,store, retrieve, display,	MIM software isintended for trainedmedical professionalsincluding, but notlimited to,radiologists,oncologists,physicians, medicaltechnologists,dosimetrists, andphysicists.MIM is a medicalimage and informationmanagement systemthat is intended toreceive, transmit,store, retrieve, display,	RayStation is asoftware system forradiation therapy andmedical oncology.Based on user input,RayStation proposestreatment plans. Aftera proposed treatmentplan is reviewed andapprovedby authorized intendedusers, RayStation mayalso be used toadminister treatments.The systemfunctionality can beconfigured based on	ClearCheck isintended to assistradiation therapyprofessionals ingenerating andassessing the qualityof radiotherapytreatment plans.ClearCheck is alsointended to assistradiation treatmentplanners in predictingwhen a treatment planmight result in acollision between thetreatment machine andthe patient or supportstructures.

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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 where they overlap. To the right of the squares is the text "mim SOFTWARE" in a sans-serif font, with "mim" in a larger font size than "SOFTWARE".

print and processdigital medicalimages, as well ascreate, display, andprint reports fromthose images. Themedical modalities ofthese medical imagingsystems include, butare not limited to, CT,MR, CR, DX, MG,US, SPECT, PET andXA as supported byACR/NEMA DICOM3.0.	print and processdigital medicalimages, as well ascreate, display, andprint reports fromthose images. Themedical modalities ofthese medical imagingsystems include, butare not limited to, CT,MRI, CR, DX, MG,US, SPECT, PET andXA as supported byACR/NEMA DICOM3.0.	user needs.
MIM provides theuser with the means todisplay, register andfuse medical imagesfrom multiplemodalities.Additionally, itevaluates cardiac leftventricular functionand perfusion,including leftventricularend-diastolic volume,end-systolic volume,and ejection fraction.	MIM provides theuser with the means todisplay, register andfuse medical imagesfrom multiplemodalities.Additionally, itevaluates cardiac leftventricular functionand perfusion,including leftventricularend-diastolic volume,end-systolic volume,and ejection fraction.
The Region of Interest(ROI) feature reducesthe time necessary forthe user to defineobjects in medicalimage volumes byproviding an initialdefinition of objectcontours. The objectsinclude, but are notlimited to, tumors andnormal tissues.MIM provides tools toquickly create,transform, and modifycontours for	The Region of Interest(ROI) feature reducesthe time necessary forthe user to defineobjects in medicalimage volumes byproviding an initialdefinition of objectcontours. The objectsinclude, but are notlimited to, tumors andnormal tissues.MIM provides tools toquickly create,transform, and modifycontours for

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Image /page/9/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 SOFTWARE" in a sans-serif font, with "mim" in a larger font size than "SOFTWARE".

applications including,but not limited to,quantitative analysis,aiding adaptivetherapy, transferringcontours to radiationtherapy treatmentplanning systems andarchiving contours forpatient follow-up andmanagement.	applications including,but not limited to,quantitative analysis,aiding adaptivetherapy, transferringcontours to radiationtherapy treatmentplanning systems andarchiving contours forpatient follow-up andmanagement.		various radioisotopes(not includingradioactivemicrospheres).MIM allowsvoxel-based dosecalculations forpatients who havebeen administeredradioisotopes orradioactivemicrospheres. MIMassists with theplanning andevaluation of ablationprocedures byallowing the energyzone that comprisesthe ablation zone to bevisualized on medicalimaging through theplacement of virtualablation devices forthe purpose ofconfirming ablationzone placement.	various radioisotopes(not includingradioactivemicrospheres).MIM allowsvoxel-based dosecalculations forpatients who havebeen administeredradioisotopes orradioactivemicrospheres. MIMassists with theplanning andevaluation of ablationprocedures byallowing the energyzone that comprisesthe ablation zone to bevisualized on medicalimaging through theplacement of virtualablation devices forthe purpose ofconfirming ablationzone placement.
MIM aids in theassessment ofPET/SPECT brainscans. It providesautomated quantitativeand statistical analysisby automaticallyregisteringPET/SPECT brainscans to a standardtemplate andcomparing intensityvalues to a referencedatabase or to otherPET/SPECT scans ona voxel-by-voxelbasis, withinstereotactic surfaceprojections orstandardized regionsof interest.	MIM aids in theassessment ofPET/SPECT brainscans. It providesautomated quantitativeand statistical analysisby automaticallyregisteringPET/SPECT brainscans to a standardtemplate andcomparing intensityvalues to a referencedatabase or to otherPET/SPECT scans ona voxel-by-voxelbasis, withinstereotactic surfaceprojections orstandardized regionsof interest.	Indications for Use	MIM software is usedby trained medicalprofessionals as a toolto aid in evaluationand informationmanagement of digitalmedical images. Themedical imagemodalities include, butare not limited to, CT,MR, CR, DX, MG,US, SPECT, PET andXA as supported byACR/NEMA DICOM3.0. MIM assists inthe followingindications:• Receive, transmit,store, retrieve, display,print, and process	MIM software is usedby trained medicalprofessionals as a toolto aid in evaluationand informationmanagement of digitalmedical images. Themedical imagemodalities include, butare not limited to, CT,MR, CR, DX, MG,US, SPECT, PET andXA as supported byACR/NEMA DICOM3.0. MIM assists inthe followingindications:• Receive, transmit,store, retrieve, display,print, and process	RayStation is asoftware system forradiation therapy andmedical oncology.Based on user input,RayStation proposestreatment plans. Aftera proposed treatmentplan is reviewed andapprovedby authorized intendedusers, RayStation mayalso be used toadminister treatments.The systemfunctionality can beconfigured based onuser needs.	ClearCheck isintended to assistradiation therapyprofessionals ingenerating andassessing the qualityof radiotherapytreatment plans.ClearCheck is alsointended to assistradiation treatmentplanners in predictingwhen a treatment planmight result in acollision between thetreatment machine andthe patient or supportstructures.
MIM allows the dosedistribution of animplant to beindividually shapedfor each patient and isa general-purposebrachytherapyplanning system usedfor prospective andconfirmation dosecalculations forpatients undergoing acourse ofbrachytherapy usingpermanent implants of	MIM allows the dosedistribution of animplant to beindividually shapedfor each patient and isa general-purposebrachytherapyplanning system usedfor prospective andconfirmation dosecalculations forpatients undergoing acourse ofbrachytherapy usingpermanent implants of

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Image /page/10/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 cut out of the red square. 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. The logo is simple and modern, and the colors are eye-catching.

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Image /page/11/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.

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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 simple and modern, with a clean design.

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Image /page/13/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 simple and modern, and the colors are eye-catching.

	Lossy compressedmammographicimages and digitizedfilm screen imagesmust not be reviewedfor primary imageinterpretations. Imagesthat are printed to filmmust be printed usingan FDA-approvedprinter for thediagnosis of digitalmammographyimages.Mammographicimages must beviewed on a displaysystem that has beencleared by the FDAfor the diagnosis ofdigital mammographyimages. The softwareis not to be used formammography CAD.	Lossy compressedmammographicimages and digitizedfilm screen imagesmust not be reviewedfor primary imageinterpretations. Imagesthat are printed to filmmust be printed usingan FDA-approvedprinter for thediagnosis of digitalmammographyimages.Mammographicimages must beviewed on a displaysystem that has beencleared by the FDAfor the diagnosis ofdigital mammographyimages. The softwareis not to be used formammography CAD.
Operating Platform	Microsoft Windows,Apple® OS X	Microsoft Windows,Apple® OS X	Windows 10Professional (orhigher), WindowsServer 2012 R2 (orhigher)	Windows OperatingSystem
Receive, transmit,display, generalmanipulation(window/level, pan,zoom, cross-hairs,slice navigation), andco-registration ofmedical images	Yes	Yes	Yes	Yes
Supported ImagingModalities	CT, MR, CR, DX,MG, US, NM, PET,XA, and otherDICOM modalities	CT, MR, CR, DX,MG, US, NM, PET,XA, and otherDICOM modalities	CT, MR, XA, PET,and other DICOMmodalities	CT, MR, XA, andother DICOMmodalities
Evaluation ofradiation dose ondifferent image setsthrough the use of	Yes	No	Yes	Yes
rigid and deformableregistration objects
Accumulation of dosefrom multiple images	Yes	No	Yes	Yes
Calculation ofBiologically EffectiveDose (BED) andEquieffective Dose inspecified fractions(e.g., EQD2)	Yes	No	Yes — added inRaystation 11B(K220141)	Yes

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Image /page/14/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. Below the text "mim" is the word "SOFTWARE" in a smaller, sans-serif font.

Device Description

Calculation of Biologically Effective Dose (BED) and Equieffective Dose in specified fractions (e.g., EQD2)
Evaluation of radiation dose on different image sets through the use of rigid and deformable ● registration objects
Accumulation of doses ●

Substantial Equivalence

MIM - Dose Analysis is substantially equivalent to the predicate device, MIM - Ablation (K220256). The technological characteristics of MIM - Dose Analysis are supported by the methods in the reference devices, RaySearch RayStation 12A (K222312) and Radformation ClearCheck (K220583).

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Image /page/15/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. Below the text "mim" is the word "SOFTWARE" in a smaller, sans-serif font.

Testing and Performance Data

Software verification and validation testing included 2 main sections: BED, EQD, and TCP calculations; and dose accumulation.

BED, EQD, and TCP calculations implemented in MIM were compared against manual calculations using the same equations referenced in literature. Several different applications of the standard Linear-Quadratic (LQ) BED Model were tested. All test results yielded dose and TCP results within acceptable clinical limits when compared to manual calculations.

Dose accumulation was tested by accumulating radiation doses delivered at separate timepoints for each patient dataset. Testing included dose accumulation between separate treatment timepoints linked via rigid and deformable registration objects. Accumulated dose was calculated in MIM at multiple data points within physician-contoured anatomical structures of interest in treatment planning and evaluation, and these dose results were compared against manual dose accumulation calculations. These test results showed consistent and accurate dose accumulation methods applied in MIM.

Altogether, the testing performed validates the adequacy of MIM - Dose Analysis for clinical use and verifies alignment between MIM software, standardized equations referenced in literature, and previously FDA-cleared softwares.

Conclusion

Based on the Device Description and Testing and Performance Data above, the proposed device is determined to be as safe and effective as the predicate device, MIM - Ablation (K220256). The technological characteristics of the proposed device are adequately supported by the methods in the reference devices. RaySearch RayStation 12A (K222312) and Radformation ClearCheck (K220583).

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).

medical images andDICOM objects.	medical images andDICOM objects.
• Create, display, andprint reports frommedical images.	• Create, display, andprint reports frommedical images.
• Registration, fusiondisplay, and review of	• Registration, fusiondisplay, and review of
medical images fordiagnosis, treatment	medical images fordiagnosis, treatment
evaluation, andtreatment planning.	evaluation, andtreatment planning.
• Evaluation of cardiacleft ventricular	• Evaluation of cardiacleft ventricular
function andperfusion, includingleft ventricular	function andperfusion, includingleft ventricular
end-diastolic volume,end-systolic volume,	end-diastolic volume,end-systolic volume,
and ejection fraction.• Localization and	and ejection fraction.• Localization and
definition of objectssuch as tumors and	definition of objectssuch as tumors and
normal tissues inmedical images.	normal tissues inmedical images.
• Creation,transformation, and	• Creation,transformation, and
modification ofcontours forapplications including,	modification ofcontours forapplications including,
but not limited to,quantitative analysis,	but not limited to,quantitative analysis,
aiding adaptivetherapy, transferringcontours to radiation	aiding adaptivetherapy, transferringcontours to radiation
therapy treatmentplanning systems, and	therapy treatmentplanning systems, and
archiving contours forpatient follow-up andmanagement.	archiving contours forpatient follow-up andmanagement.
• Quantitative andstatistical analysis ofPET/SPECT brain	• Quantitative andstatistical analysis ofPET/SPECT brain
scans by comparing to	scans by comparing to
other registeredPET/SPECT brainscans.	other registeredPET/SPECT brainscans.
• Planning andevaluation ofpermanent implantbrachytherapyprocedures (notincluding radioactivemicrospheres).	• Planning andevaluation ofpermanent implantbrachytherapyprocedures (notincluding radioactivemicrospheres).
• Calculating absorbedradiation dose as aresult of administeringa radionuclide.	• Calculating absorbedradiation dose as aresult of administeringa radionuclide.
• Assist with theplanning andevaluation of ablationprocedures byprovidingvisualization andanalysis, includingenergy zonevisualization throughthe placement ofvirtual ablationdevices validated forinclusion inMIM-Ablation. Thesoftware is notintended to predictspecific ablation zonevolumes or predictablation success.	• Assist with theplanning andevaluation of ablationprocedures byprovidingvisualization andanalysis, includingenergy zonevisualization throughthe placement ofvirtual ablationdevices validated forinclusion inMIM-Ablation. Thesoftware is notintended to predictspecific ablation zonevolumes or predictablation success.
When using the deviceclinically, within theUnited States, the usershould only use FDAapprovedradiopharmaceuticals.If used withunapproved ones, thisdevice should only beused for researchpurposes.	When using deviceclinically, within theUnited States, the usershould only use FDAapprovedradiopharmaceuticals.If using withunapproved ones, thisdevice should only beused for researchpurposes.