ILUMIEN systems are subject to US Patent 8,325,419, GB, FR, CH, IT Patents 0581871, DE 69227902; GB, FR 0883793, DE 69738291. ILUMIEN, ST. JUDE MEDICAL, LIGHTLAB IMAGING, GOLDEN IMAGE and the color gold are registered or unregistered trademarks of St. Jude Medical, Inc. and its related companies.
ILUMIEN systems enabled for FFR may also be subject to US Patent 6,565,514.
Please note St. Jude Medical, Inc. and its related companies, including but not limited to LightLab Imaging, Inc., make no representation or warranty that use of the Ilumien System complies with applicable privacy, security and confidentiality laws, but encourages you to assess your own risk as you use, disclose, control, process or transfer patient health information with the Ilumien System.
Software component licenses
Certain Software Components in the ILUMIEN System are provided under one or more of the following Licenses:
|
Software Component |
License |
|---|---|
|
Microsoft® Windows XP Professional |
|
|
Microsoft® OEM Customer License Agreement for Embedded Systems |
Customer License Agreement 4.1 Part 2 [PDF 326KB] |
|
Intel® JPEG Library |
Intel® JPEG Library License Agreement [PDF 49.9KB] |
|
Microsoft® MPEG-4 Video Codec |
WM9 Supplemental End User License Agreement [PDF 57KB] |
|
ATI® Radeon® HD 4650 Display Adapter Driver |
ATI End User License Agreement [PDF 17.3KB] |
|
Microsoft® Foundation Class Library |
|
|
Microsoft® Standard C++ Library |
|
|
LEADTOOLS® Medical Imaging Suite SDK |
LEADTOOLS Software License Agreement (EULA) [PDF 58.8KB] |
|
Microsoft® SQL Server Express 2008 Service Pack 2 (SP2) |
|
|
DAS FPGA Flashloader |
GNU General Public License, Version 3, 29 June 2007 [PDF 79.3KB] |
|
Droid Sans Font |
Apache License, Version 2.0, January 2004 [PDF 231KB] |
Research-only software features
The following optional Research-Only Features, which may be enabled for a customer’s offline software installation only (Offline Review Workstation or stand-alone software installation on customer PC), are not approved by FDA or any other applicable regulatory agency:
|
Release Designator |
Release Designator Research-Only Features Present in Release |
|---|---|
|
Release Designator |
Research Options; Tissue Property Measurements |
|
C.0.4 |
Research Options; Tissue Property Measurements |
|
D.0.1 |
Research Options; Tissue Property Measurements |
|
D.0.2 |
Research Options; Tissue Property Measurements |
|
E.0.1 |
Research Options; Tissue Property Measurements |
Research-only feature definitions:
- Research Options: Neointimal Thickness Measurement, Thickness Ruler, Stent Annotation, and Angle and Pie measurements.
- Tissue Property Measurements: provides tissue analysis capabilities through the measurement of attenuation and backscatter for specified regions of interest on an OCT image.
Research-only options may not be used for any purpose other than a purpose that has been specifically approved by the FDA or other applicable regulatory agency and are provided solely for Licensee’s internal research purposes in connection with the review and analysis of medical imaging and physiologic information collected on a PCI Optimization System. Research-Only Features may never be enabled on a PCI Optimization System and may never be used in the course of diagnosing or treating patients. Customer agrees that to the extent Customer publishes the results of any research which makes use of or incorporates results from Research-Only Features, Customer will include a statement noting the regulatory status of the Research-Only Features.
Please direct any ILUMIEN product or legal inquiries to Customer Service.
GLXY‐COR‐0416‐0020a