(56 days)
Not Found
No
The document describes image registration, fusion, and display tools, which are standard image processing techniques and does not mention AI, ML, or related concepts.
No
The device is described as software for diagnostic imaging, specifically for image review, manipulation, and analysis to assist physicians. There is no mention of treating or preventing diseases.
Yes
Explanation: The "Device Description" explicitly states, "MIMviewer is a software package designed for use in diagnostic imaging." Additionally, the "Intended Use / Indications for Use" section mentions that the software's tools "assist physicians" in reviewing, manipulating, and analyzing medical images, which are common activities in the diagnostic process.
Yes
The device description explicitly states "MIMviewer is a software package" and describes its operation on standard computer operating systems. There is no mention of accompanying hardware components.
Based on the provided information, the MIMviewer software program is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MIMviewer's function: MIMviewer's intended use and description clearly state that it is for the registration, fusion, display, review, manipulation, and analysis of medical images from modalities like SPECT, PET, CT, and MRI. These are imaging modalities that capture images of the inside of the body, not analyze biological specimens.
- No mention of biological specimens: The document does not mention the analysis of any biological samples.
Therefore, MIMviewer falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MIMviewer software program is used for the registration, fusion and display of medical images from multi-modalities, such as SPECT, PET, CT, and MRI. MIMviewer provides tools for image review, manipulation, and analysis that assist physicians both inside and outside the medical environment.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
MIMviewer is a software package designed for use in diagnostic imaging which operates on Windows 2000/XP, MacOS X 10.4+ and Linux. MIMviewer is designed to be used as a standalone software package, as a remote viewing client for the MIM (K060816) software package, or as CD-ROM DICOM viewer for referring physicians. MIMviewer provides the physician with the means to display, register and fuse medical images from multiple modalities including PET, SPECT, CT and MRI.
Mentions image processing
System, Imaging Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, SPECT, CT and MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians both inside and outside the medical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MIMvista has conducted performance and functional testing on the MIMviewer software. In all cases, the software passed its' performance requirements and met specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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
Kol 2163
MIMvista Corp.
Page 1 of 1
510(k) Summary of Safety and Effectiveness
(The following information is in conformance with 21 CFR 807.92)
Submitter:
SEP 2 2 2006
| MIMvista Corp.
25200 Chagrin Blvd. Suite 200
Cleveland, OH 44122
Phone:
Fax: | 216-896-9798
216-896-9796 | |
|------------------------------------------------------------------------------------------|------------------------------|--|
| Contact Person: | Peter Simmelink | |
| Date Summary Prepared: | July 27, 2006 | |
| Device Name | | |
| Trade Name: | MIMviewer 1.0 | |
| Trade Name: | MIMviewer 1.0 |
|---|---|
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Imaging Processing, Radiological |
Predicate Devices
MIMvista Corp. K060816 MIM 4.0
Intended Use
MIMviewer is a software package that aids the physician in the diagnosis of patients by means of medical images. MIMviewer is used to display, register and fuse medical images from multiple modalities.
Device Description
MIMviewer is a software package designed for use in diagnostic imaging which operates on Windows 2000/XP, MacOS X 10.4+ and Linux. MIMviewer is designed to be used as a standalone software package, as a remote viewing client for the MIM (K060816) software package, or as CD-ROM DICOM viewer for referring physicians. MIMviewer provides the physician with the means to display, register and fuse medical images from multiple modalities including PET, SPECT, CT and MRI.
Substantial Equivalence
MIMviewer™ is substantially equivalent to MIM™ 4.0 (NEURO) software (K060816).
Performance Data
MIMvista has conducted performance and functional testing on the MIMviewer software. In all cases, the software passed its' performance requirements and met specifications.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 2 2006
Mr. Peter Simmelink Chief Operating Officer MIMvista Corp. 25200 Chagrin Blvd., Suite 200 CLEVELAND OH_44122
Re: K062163
Trade/Device Name: MIMviewer Regulation Number: 21 CFR $892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 27, 2006 Received: July 28, 2006
Dear Mr. Peter Simmelink:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/1/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in a stylized font. The word "Centennial" is written below the acronym. Three stars are at the bottom of the logo. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.
Sing Public . H.
2
Page 2 -
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
15062163 510(k) Number (if known): __FBB
Device Name: MIMviewer
Indications for Use:
The MIMviewer software program is used for the registration, fusion and display of medical images from multi-modalities, such as SPECT, PET, CT, and MRI. MIMviewer provides tools for image review, manipulation, and analysis that assist physicians both inside and outside the medical environment.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Legum
(Division Sign-Off) Division of Reproductive. Abdomin and Radiological Devices
510(k) Number K062163
(Posted November 13, 2003)
1
Page 1 of 1