MIMVIEWER

K062163 · Mimvista Corp. · LLZ · Sep 22, 2006 · Radiology

Device Facts

• Record ID: K062163
• Device Name: MIMVIEWER
• Applicant: Mimvista Corp.
• Product Code: LLZ · Radiology
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 Story

MIMviewer is a software package for diagnostic imaging; operates on Windows, MacOS, and Linux. Inputs include medical images from multiple modalities (PET, SPECT, CT, MRI). Device functions as a standalone viewer, remote client for MIM (K060816), or CD-ROM DICOM viewer. Provides tools for image display, registration, and fusion. Used by physicians in clinical environments to assist in patient diagnosis. Output is visualized medical imagery; aids clinical decision-making by enabling multi-modal image comparison and analysis.

Clinical Evidence

Bench testing only. Performance and functional testing conducted; software met all performance requirements and specifications.

Technological Characteristics

Software-based medical imaging system. Compatible with Windows 2000/XP, MacOS X 10.4+, and Linux. Supports DICOM standard. Functions include image display, registration, and fusion of PET, SPECT, CT, and MRI modalities.

Indications for Use

Indicated for the registration, fusion, and display of medical images from multi-modalities including SPECT, PET, CT, and MRI to assist physicians in image review, manipulation, and analysis.

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 4.0 (K060816)

Submission Summary (Full Text)

{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.<br>25200 Chagrin Blvd. Suite 200<br>Cleveland, OH 44122<br>Phone:<br>Fax: | 216-896-9798<br>216-896-9796 | |
|------------------------------------------------------------------------------------------|------------------------------|--|
| Contact Person: | Peter Simmelink | |
| Date Summary Prepared: | July 27, 2006 | |
| <b>Device Name</b> | | |
| 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 [phone] or [phone]

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