(74 days)
Not Found
No
The document describes standard image processing techniques (registration, fusion, MPR, MIP, ROI analysis) and does not mention AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies sections. The automated registration mentioned for hybrid scanners relies on parameters provided in the image headers, not on learned algorithms.
No.
UniSyn is a software application for image processing and display of scanned medical image data, providing tools for registration, fusion, and measurement. It is intended for use by medical professionals to assist in the visualization and analysis of medical images, rather than directly treating or diagnosing a condition. Its function is to process and present information from existing scans, not to exert a direct therapeutic effect on a patient.
Yes
Explanation: The device is used by qualified radiology and nuclear medicine professionals to register and fuse medical images and provides measurements like area, volume, and Standard Uptake Values (SUVs), which are used in disease assessment and diagnosis.
Yes
The device description explicitly states "UniSyn is a software only package". The functionality described is entirely software-based image processing and display, and it runs on standard computer hardware.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- UniSyn's Function: UniSyn processes and displays scanned image data from medical imaging modalities (CT, PET, SPECT, MR). It does not analyze biological samples taken from a patient. Its purpose is to manipulate and visualize existing image data for diagnostic interpretation by qualified professionals.
The description clearly indicates that UniSyn is an image processing and display software for medical images, not a device that performs tests on biological specimens.
N/A
Intended Use / 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-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.
Product codes
LLZ
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
- 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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, PET, SPECT, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified radiology and nuclear medicine professionals.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
49 First Avenue, Suite B
Ottawa, Ontario K1S 2G1, Canada |
|------------------|---------------------------------------------------------------------------------------------|
| SEP 2 6 2008 | |
-
- Date of Preparation: July 02, 2008
3. Name, Title and Phone Number of Contact
| Mathew A. Thomas | |
|---|---|
| Phone: 613-239-0421 | Fax, 801-315-9085 |
4. Tradename and Common Name of the Device
| Tradename: | UniSyn |
|---|---|
| Common Name: | Image Processing (Image Fusion) |
| 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
1
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
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
outlines and fiducial markers | ✓ | | | |
| export of 3D contours for treatment
planning | ✓ | | | |
2
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.
3
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.
4
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 (800) 638-2041 or (240) 276-3150 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
5
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 _