Who is the manufacturer of MIM-Ablation?

Mim Software, Inc. filed the 510(k) submission for MIM-Ablation (K220256).

What is the FDA product code for MIM-Ablation?

QTZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MIM-Ablation?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MIM-Ablation?

MIM on Linux (K190379); Aline Ablation Intelligence (K202297).

Who can help prepare an FDA 510(k) submission like MIM-Ablation?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MIM-Ablation

K220256 · Mim Software, Inc. · QTZ · Oct 7, 2022 · Radiology

Device Facts

Record ID	K220256
Device Name	MIM-Ablation
Applicant	Mim Software, Inc.
Product Code	QTZ · Radiology
Decision Date	Oct 7, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

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

Device Story

MIM-Ablation is a standalone software application for ablation procedure planning and evaluation. It inputs 3D DICOM images (CT, MRI, etc.) and allows clinicians to place virtual ablation devices to visualize energy zones. The device transforms these inputs by overlaying pre-defined energy zone models onto patient images, enabling manual/automatic segmentation of targets and ablation zones, image re-slicing for 'probe's-eye views,' and multimodality registration (rigid/deformable). It calculates the percentage of target structures covered by energy zones. Used in hospital environments by physicians/technologists, the output provides visualization and quantitative analysis to assist in confirming ablation zone placement and planning. It does not predict ablation success or specific volumes. Benefits include improved visualization and planning accuracy for ablation procedures.

Clinical Evidence

Bench testing only. Verification and validation testing evaluated energy zone dimensions, image resolution independence, contour resolution independence, modality independence, and percent coverage accuracy. Results showed percent differences for energy zone volumes ranging from -1.65% to 0.29% across resolutions and 0.64% to 0.89% across modalities. HIFU dimension measurements showed percent error between 0.00% and 6.00%. Constraint-driven planning functionality was verified to adhere to user-defined constraints.

Technological Characteristics

Standalone software; runs on Windows/OS X workstations. Supports DICOM 3.0. Features: 3D image segmentation, multimodality registration (rigid/deformable), virtual ablation device placement, and energy zone visualization. Algorithm class: Rule-based/geometric modeling. No hardware components. Sterilization not applicable.

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 function evaluation, ROI definition, contouring, PET/SPECT brain scan analysis, brachytherapy planning, and ablation procedure planning/evaluation via virtual ablation device placement. Not for mammography CAD. Not intended to predict ablation zone volumes or success. Use only FDA-approved radiopharmaceuticals for clinical use.

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)
Aline Ablation Intelligence (K202297)

Reference Devices

MIM-Brachy (K103576)
CryoCare Touch System (K201588)
SonaBlate HIFU system (K160942)

Related Devices

K202297 — Aline Ablation Intelligence · Mirada Medical, Ltd. · Sep 11, 2020
K240796 — myAblation Guide (VB80A) · Siemens Healthcare GmbH · Aug 6, 2024
K251931 — BioTraceIO Vision (V1.7) · Techsomed Medical Technologies · Sep 8, 2025
K192427 — Ablation Confirmation · Neuwave Medical, Inc. · Oct 3, 2019
K171022 — Ablation Confirmation · Neuwave Medical, Inc. · May 9, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below. MIM Software, Inc. % Daniel Darkow Clinical Science Team Lead 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122 Re: K220256 October 7, 2022 Trade/Device Name: MIM-Ablation Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QTZ, LLZ Dated: September 2, 2022 Received: September 6, 2022 Dear Daniel Darkow: 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 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) {1}------------------------------------------------ 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, Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220256 Device Name MIM - Ablation 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, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. · Localization and definition of objects such as tumors and normal tissues in medical images. · Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Quantitative and statistical analysis of PE7/SPECT brain scans by comparing to other registered PET/SPECT brain scans. · Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). · Calculating absorbed radiation dose as a result of administering a radionuclide. · Assist with the planning and evaluation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success. When using device clinically, within the United States, the user should only use FDA approved radionly, If using with unapproved ones, this device should only be used for research purposes. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD. 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. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 in the red square. To the right of the squares is the text "mim SOFTWARE" in black, with "SOFTWARE" in a smaller font size than "mim". # 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 216-455-0601 Fax: Contact Person: Daniel Darkow Date Summary Prepared: 10/04/2022 #### Device Name | 510(k) Number: | K220256 | |---------------------------------------------|-------------------------------------------------------------------------------------| | Trade Name: | MIM – Ablation | | Common Name: | Medical Imaging Software | | Primary Regulation Number/Product Code: | 21 CFR 892.2050 Product Code QTZ | | Primary Classification Name: | Radiological Image Processing Software for Ablation Therapy Planning and Evaluation | | Secondary Regulation Number / Product Code: | 21 CFR 892.2050 Product Code LLZ | | Secondary Classification Name: | System, Imaging Processing, Radiological | Predicate Devices # Predicate Devices | Primary: K190379 | MIM on Linux | MIM Software Inc. | |-------------------------|-----------------------------|---------------------| | Secondaries: K202297 | Aline Ablation Intelligence | Mirada Medical Ltd. | #### 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a gray square overlapping a red square with a white circle cut out of the corner. To the right of the squares is the text "mim SOFTWARE" in black font. The word "SOFTWARE" is in a smaller font than "mim". 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 eiection 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 visualized on medical imaging through the placement of virtual ablation devices for the purpose of confirming ablation zone placement. #### 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: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for MIM Software. The logo consists of a red square with rounded corners and a white circle in the lower left corner. A gray square with rounded corners is behind the red square. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the text "SOFTWARE" in a smaller, sans-serif font. • 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 device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If using with unapproved ones, this device should only be used for research purposes. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using 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. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a red square with rounded corners and a white circle cut out of the top right corner. To the left of the red square is a gray square with rounded corners. To the right of the squares is the text "mim SOFTWARE" in black font. | ITEM | MIM – Ablation (K220256) | MIM on Linux (K190379) | Mirada Aline Ablation Intelligence (K202297) | |-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clearance Date | TBD | 03-19-2019 | 09-11-2020 | | 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 | 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 | Not listed | | ITEM | MIM - Ablation (K220256) | MIM on Linux (K190379) | Mirada Aline Ablation Intelligence (K202297) | | | end-diastolic volume, end- systolic volume, and ejection fraction. | 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. | 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 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 | 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 | | | ITEM | MIM – Ablation (K220256) | MIM on Linux (K190379) | Mirada Aline Ablation Intelligence (K202297) | | | 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 visualized on medical imaging through the placement of virtual | 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. | | | ITEM | MIM – Ablation (K220256) | MIM on Linux (K190379) | Mirada Aline Ablation Intelligence (K202297) | | | ablation devices for the purpose of confirming ablation zone placement. | | | | 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, 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. | 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- diastolic volume, end- systolic volume, and ejection fraction. | Aline Ablation Intelligence is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures. Aline Ablation Intelligence is controlled by the user via a user interface on a workstation. Aline Ablation Intelligence imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures. Aline Ablation Intelligence is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. Aline Ablation Intelligence is used to assist physicians in confirming ablation zones. The software is not intended for diagnosis. | | ITEM | MIM – Ablation (K220256) | MIM on Linux (K190379) | Mirada Aline Ablation Intelligence (K202297) | | | • 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- | • 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. | The software is not intended to predict ablation volumes or predict ablation success. | | ITEM | MIM - Ablation (K220256) | MIM on Linux (K190379) | Mirada Aline Ablation Intelligence (K202297) | | | Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success. | When using device clinically, the user should only use FDA approved radiopharmaceuticals. | | | | When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. | If using with unapproved ones, this device should only be used for research purposes. | | | | If using with unapproved ones, this device should only be used for research purposes. | Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. | | | | 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. | | | | 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. |…