(60 days)
Not Found
No
The document describes image viewing, registration, fusion, and display software. It mentions image processing but does not contain any terms or descriptions indicative of AI/ML technology, such as "AI," "ML," "deep learning," "neural network," or descriptions of training/test sets for such algorithms.
No.
The device is used for viewing, registration, fusion, and display of medical images for diagnosis, as well as for reviewing and approving radiation treatment plans. It does not directly provide therapy.
Yes
The software is explicitly stated to be "used for the viewing, registration, fusion, and/or display for diagnosis of medical images" from various modalities (SPECT, PET, CT, MRI, X-ray, Ultrasound), which is a key function of diagnostic devices in medical imaging.
Yes
The device description explicitly states "Mobile MIM (RT) extends the Mobile MIM software application" and the performance studies focus on software testing and display quality on different devices, indicating it is a software-only product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device's intended use is for the viewing, registration, fusion, and display of medical images from various imaging modalities (SPECT, PET, CT, MRI, X-ray, Ultrasound) and for reviewing/approving radiation treatment plans. These are all related to analyzing images and treatment data, not analyzing biological specimens.
The description clearly focuses on image processing and display for diagnostic and treatment planning purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Mobile MIM software program is used for the viewing, registration, fusion, and/or display for diagnosis of medical images from the following modalities: SPECT, PET, CT, MRI, X-ray and Ultrasound.
Mobile MIM can be used to review images, contours, DVH, and isodose curves from radiation treatment plans. Mobile MIM can be used to approve these plans.
Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
Product codes
LLZ, MUJ
Device Description
Mobile MIM (RT) extends the Mobile MIM software application previous cleared under K103785. In addition to SPECT. PET. CT. MRI modalities. Mobile MIM can be used for the viewing and/or display for diagnosis of X-ray and Ultrasound medical images.
It also provides functionality for the review of medical images, contours. DVH, and isodose curves from radiation treatment plans. In addition. Mobile MIM (RT) will allow permitted users the ability to approve reviewed radiation treatment plans.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
SPECT, PET, CT, MRI, X-ray and Ultrasound
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MIM Software Inc. has performed multiple studies with qualified radiologists. dosimetrists and radiation oncologists. Radiologists tested Mobile MIM by evaluating the image quality of the two additional modalities of X-ray and Ultrasound under different environmental conditions. Results of these studies affirm the diagnostic image viewing capabilities of Mobile MIM when used as indicated.
MIM Software also orchestrated radiation therapy plan review tests evaluating multiple areas of treatments by trained medical professionals using plan data from 3 major vendors, and using both smaller format (iPhone and/or iPod touch) and larger format (iPad) devices. The results indicated the display quality for of isodose curves, DVH graphs, and contours was of acceptable quality for review and approval of radiation therapy plans, and were equivalent to those viewed on a full workstation.
Furthermore, MIM Software Inc. has conducted verification, validation, and functional testing on the Mobile MIM software. In all cases, the software passed its performance requirements and met specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
Image /page/0/Picture/0 description: The image shows a logo for MIM Software. The logo consists of two overlapping squares with a circle in the middle on the left side. To the right of the squares are the letters "mim" in a stylized font, with the word "SOFTWARE" below it in smaller letters.
Image /page/0/Picture/1 description: The image shows the text "K112930 Page 1 of 3". The text appears to be handwritten in a dark ink. The text "Page 1 of 3" is located below the other text and is smaller in size.
DEC - 2 2011
510(k) Summary of Safety and Effectiveness
(The following information is in conformance with 21 CFR 807.92)
Submitter:
MIM Software Inc. 25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122
| Phone: | 216-455-0600 |
|---|---|
| Fax: | 216-455-0601 |
| Contact Person: | Lynn Hanigan |
| Date Summary Prepared: | Sept 30, 2011 |
Device Name
| Trade Name: | Mobile MIM (RT) |
|---|---|
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Imaging Processing, Radiological |
Predicate Device
| K103785 | Mobile MIM | MIM Software Inc. |
|---|---|---|
| K042956 | Vision | Varian Medical System |
Intended Use / Indications for Use
The Mobile MIM software program is used for the viewing, registration, fusion, and/or display for diagnosis of medical images from the following modalities: SPECT, PET, CT, MRI, X-ray and Ultrasound.
Mobile MIM can be used to review images, contours, DVH, and isodose curves from radiation treatment plans. Mobile MIM can be used to approve these plans.
Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
1
Image /page/1/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a black square with a white circle in the center, followed by 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
Mobile MIM (RT) extends the Mobile MIM software application previous cleared under K103785. In addition to SPECT. PET. CT. MRI modalities. Mobile MIM can be used for the viewing and/or display for diagnosis of X-ray and Ultrasound medical images.
It also provides functionality for the review of medical images, contours. DVH, and isodose curves from radiation treatment plans. In addition. Mobile MIM (RT) will allow permitted users the ability to approve reviewed radiation treatment plans.
Substantial Equivalence
Mobile MIM is substantially equivalent to Mobile MIM software (K103785) and portions of the Vision product (K042956). It extends Mobile MIM functionality by adding 2 additional image modalities to its indication and having the capability to serve as a mobile reviewing device for radiation treatment plans.
Performance Data
MIM Software Inc. has performed multiple studies with qualified radiologists. dosimetrists and radiation oncologists. Radiologists tested Mobile MIM by evaluating the image quality of the two additional modalities of X-ray and Ultrasound under different environmental conditions. Results of these studies affirm the diagnostic image viewing capabilities of Mobile MIM when used as indicated.
MIM Software also orchestrated radiation therapy plan review tests evaluating multiple areas of treatments by trained medical professionals using plan data from 3 major vendors, and using both smaller format (iPhone and/or iPod touch) and larger format (iPad) devices. The results indicated the display quality for of isodose curves, DVH graphs, and contours was of acceptable quality for review and approval of radiation therapy plans, and were equivalent to those viewed on a full workstation.
Furthermore, MIM Software Inc. has conducted verification, validation, and functional testing on the Mobile MIM software. In all cases, the software passed its performance requirements and met specifications.
2
Image /page/2/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a graphic on the left and the text "mim SOFTWARE" on the right. The graphic is made up of two overlapping squares with a circle in the center. The text is in a sans-serif font, with "mim" in a larger font size than "SOFTWARE".
Conclusion
Therefore, from all evidence gathered, it is our belief that Mobile MIM (RT) provides a safe and effective diagnostic viewer of the following medical imaging modalities: SPECT, PET, CT, MRI, X-ray and Ultrasound. It also is safe and effective in that it is substantially equivalent to the radiation treatment plan review functionality of Vision (K042956), allowing for portable device characteristics and accessibility when there is no access to a full workstation.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design. The caduceus is a common symbol associated with healthcare and medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DEC - 2 2011
Ms. Lynn Hanigan Quality Manager MIM Software, Inc. 25200 Chagrin Blvd. Suite 200 CLEVELAND OH 44122
Re: K112930 Trade/Device Name: Mobile MIM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ & MUJ Dated: September 30, 2011 Received: October 3, 2011
Dear Ms. Hanigan:
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. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S. Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
K112930
P. 1 of 1
Indications for Use
510(k) Number (if known): TBD KII2930
Device Name: Mobile MIM
Indications for Use:
The Mobile MIM software program is used for the viewing, registration, fusion, and/or display for diagnosis of medical images from the following modalities: SPECT, PET, CT, MRI, X-ray and Ultrasound.
Mobile MIM can be used to review images, contours, DVH, and isodose curves from radiation treatment plans. Mobile MIM can be used to approve these plans.
· Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112930