UNISYN IMAGE FUSION, VERSION 1.0

K081987 · Convergent Imaging Solutions · LLZ · Sep 26, 2008 · Radiology

Device Facts

• Record ID: K081987
• Device Name: UNISYN IMAGE FUSION, VERSION 1.0
• Applicant: Convergent Imaging Solutions
• Product Code: LLZ · Radiology
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT and MR scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.

Device Story

UniSyn is a software-only application for Intel-compatible PCs running Windows. It ingests scanned image data from CT, PET, SPECT, and MR scanners. The device enables manual image registration via UI widgets and automated registration for hybrid PET-CT/SPECT-CT scanners using header parameters. It provides multi-planar reformat (MPR), image triangulation, fusion display with variable opacity, Maximum Intensity Projection (MIP), and 3D/surface rendering. Users can define regions of interest to calculate area, volume, and Standard Uptake Values (SUV). The software supports user-configurable layouts and screen capture. Used in clinical settings by radiology and nuclear medicine professionals, the device assists in visualizing and quantifying multi-modality data to support clinical decision-making and diagnostic assessment.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technological features and intended use to legally marketed predicate devices.

Technological Characteristics

Software-only application; runs on Intel Pentium or higher compatible PCs with Microsoft Windows XP or later. Features include manual/automated image registration, MPR, MIP, 3D/surface rendering, and quantitative analysis (SUV, volume, area). Connectivity via proprietary image format loading/writing. No specific hardware requirements beyond standard PC architecture.

Indications for Use

Indicated for qualified radiology and nuclear medicine professionals to perform image registration, fusion display, and quantitative analysis (area, volume, SUV) of CT, PET, SPECT, and MR scan data.

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

• Syntegra Image Fusion (K041182)
• Medical Image Merge (K001276)

Submission Summary (Full Text)

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KO81997

## CONVERGENT IMAGING SOLUTIONS

UniSyn 510(k) Summary of Safety and Effectiveness July 2, 2008

# 510(k) Summary of Safety and Effectiveness

(APPENDIX II)

| 1. Submitted by: | Convergent Imaging Solutions<br>49 First Avenue, Suite B<br>Ottawa, Ontario K1S 2G1, Canada |
|------------------|---------------------------------------------------------------------------------------------|
| SEP 2 6 2008 | |

- 2. Date of Preparation: July 02, 2008
### 3. Name, Title and Phone Number of Contact

| Mathew A. Thomas | |
|---------------------|-------------------|
| Phone: [phone] | Fax, 801-315-9085 |

### 4. Tradename and Common Name of the Device

| Tradename: | UniSyn |
|--------------|---------------------------------------------|
| Common Name: | Image Processing (Image Fusion)<br>Software |

#### 5. Intended Use

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT and MR scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.

### 6. Device Description

UniSyn is a software only package designed for use on Intel Pentium and higher compatible computers running Microsoft Windows XP and later operating systems. It loads and writes images using a proprietary format.

UniSyn provides the following features:

- � manual registration of images, where users can use user interface widgets to align the images in three dimensions;
- automated registration of images from hybrid PET-CT and SPECT-CT scanners, . which provide the registration parameters in their image headers;
- multi-planar reformat (MPR) and image triangulation using cursors: linked . transverse, sagittal and coronal views. When the user moves a cursor on one view, the corresponding orthogonal planes of the image are computed and displayed on the other.
- . image fusion with variable opacity
- . Maximum Intensity Projection (MIP)
- � 3D Render

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## Convergent Imaging SOFUTIONS

UniSyn 510(k) Summary of Safety and Effectiveness July 2. 2008

- . Surface Render
- 2D regions of interest and 2D statistics such as area .
- 3D volumes of interest and 3D statistics such as volume, average Standard Uptake ● Value (SUV) and maximum SUV
- user configurable layouts: type of image (ie which modality and what type of . display: one of MIP, MPR/), size, color map, position - can be preconfigured;
- triangulation from MIP image: if the user clicks on the MIP image when it is in the coronal view, the MPR/fusion displays will update their position to that point
- color maps individually assigned for fusion and non-fusion views .
- screen capture to clipboard and to disk ●

| 7. Predicate Device: | Common Name: | Syntegra Image Fusion |
|----------------------|---------------------------------------|-----------------------|
| | Manufacturer: Philips Medical Systems | |
| | 510K#: | K041182 |

Comon Name: Medical Image Merge (Image Fusion) Manufacturer: Syntermed (now MIM Vista) K001276

### 8. Technological Comparison to Predicate Devices:

510K#:

| Feature | Syntegra | Medical<br>Image Merge | UniSyn | Comments |
|-----------------------------------------------------------------------|----------|------------------------|--------|--------------------|
| software device | ✓ | ✓ | ✓ | |
| intended use | | | | Similar. |
| multimodality registration | ✓ | ✓ | ✓ | Identical feature. |
| multimodality fusion display | ✓ | ✓ | ✓ | Identical feature. |
| fusion opacity control | ✓ | ✓ | ✓ | Identical feature. |
| Regions of Interest | ✓ | ✓ | ✓ | Identical feature. |
| Standard Uptake Value Calculation | ✓ | ✓ | ✓ | Identical feature. |
| Multiplanar reformat with triangulation | ✓ | ✓ | ✓ | Identical feature. |
| Maximum Intensity Projection | ✓ | ✓ | ✓ | Identical feature. |
| 3D (Surface) Render | ✓ | ✓ | ✓ | Identical feature. |
| Variable color maps | ✓ | ✓ | ✓ | Identical feature. |
| configurable image presentation layouts | ✓ | ✓ | ✓ | Identical feature. |
| PC hardware | ✓ | ✓ | ✓ | Identical feature. |
| automated registration using patient<br>outlines and fiducial markers | ✓ | | | |
| export of 3D contours for treatment<br>planning | ✓ | | | |

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# Convergent Imaging SOI UTIONS

UniSyn 510(k) Summary of Safety and Effectiveness July 2, 2008

#### Conclusion:

UniSyn is substantially equivalent to the predicate devices Syntegra and Medical Image Merge, in terms of its image processing and display capability. UniSyn does not introduce any new features or issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be a bird or abstract human figure, composed of three curved lines that converge at the bottom.

SEP 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mathew A. Thomas Convergent Imaging Solutions 49 First Avenue, Suite B OTTAWA ONTARIO K1S 2G1 CANADA

Re: K081987

Trade/Device Name: UniSyn Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communication System Regulatory Class: II Product Code: LLZ Dated: August 25, 2008 Received: September 2, 2008

#### Dear Mr. Thomas:

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 (PMA), 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.

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#### 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Jaque In Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

( APPENDIX III)

| 510K Number (if known): | K081987 |
|-------------------------|------------------------------|
| DEVICE NAME: | UniSyn |
| SUBMITTER NAME: | CONVERGENT IMAGING SOLUTIONS |

#### INDICATIONS FOR USE:

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT and MR scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planer reformand maximum intensity projection displays of the data and provides measurements such an area, volume and Standard Uptake Values for user defined regions on the image.

(Please do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _