Industry Partnerships

       

Introduction

UltraVision Corporation has and is willing to supply qualified businesses with the components and software for them to incorporate an ultrasonic imaging system into their product or application. These design and supply agreements we call Industry Partnerships.

The Industry Partner may also produce any or all of the components for the UltraVision under a license. Keys in the system exist to control the licensing.

The Partner may choose to not re-label the system and proceed to market under UltraVision’s regulatory approvals.

The product is further defined as:

  1. A Clinical Platform where the functionality is simplified and restricted in acoustic power output and modes so a physician and sonographer can easily use the system and the Clinical Platform is in conformance with an existing FDA 510K held by UltraVision.
  2. A Research Platform where its functionality is capable of changing the transmit power and the modes and virtually any function may be evaluated and optimized which is its intended use, before submitting to for regulatory approvals.
  3. Sub-assemblies and components of the UltraVision that the Partner may assemble into a marketable system.
  4. A C++ or C# Application Programming Interface (API) supplied by UltraVision so the OEM can program their own Graphical User Interface (GUI) or specific ultrasound process.

UltraVision maintains a transducer test facility and so can measure the acoustic output of any transducer and add it to our Transducer Device File, usually within several weeks of receiving three transducers of identical type. A new FDA submission is needed only when there is a new Indication for use. Otherwise a new the transducer’s acoustic measurement must be measured and placed in the design file for FDA regulatory compliance.  The Indications for use that UltraVision has approved 510K’s submissions for at the moment are small parts (breast, testis, and thyroid), superficial muscular skeletal, abdominal, and peripheral vessel.

UltraVision does maintain a Quality Control program and is ISO 13485 (2016) and ISO 9001(2008) compliant. The OEM would be required to have the product label contain the UltraVision GUDID to utilize these facilities.

UltraVision does not maintain a RF emissions and susceptibility facility but we do have experience and maintain relations with regulatory approved laboratories who can provide this service rapidly.

 A live or skype demonstration can be given and UltraVision can create specific images for the OEM area of interest.

*(An OEMs is a manufacturer who resells another company’s product under their own name and branding).

**(An ODM is an original design manufacturer that designs and manufactures a product, as specified, that is eventually rebranded by another firm for sale.)

Software

            The system’s software comprises of:

  1.  A Graphical User Interface via a touch screen with a User Manual written in English.  The software is written in C# and Windows Presentation Foundation (WPF).
  2. An API is available where a programmer can use a C++ interface to adapt new hardware, transducers and accommodate different languages and GUI designs.
  3. The system software includes a Direct X11 it may be used with tools in Windows 7, 8, and10.
  4. As a Clinical Platform the distributer may choose what options ship in the basic system and what is installed and sold at an extra cost to the end user.
  5. The UP1 board contains a Kintex Field Programable Array which is programmed in VHDL and is usually reserved for UltraVision to supply whatever changes the OEM requests.
  6. The software contains a SQL patient data base where the patient demographics and images are archived and edited.  The output of this data base is DICOM compatible.
  7. The software supports a Windows-based user login for security so the OEM can pass on login keys to system administrators who may then maintain the system security and pass this on to sonographers..

The Administrator can create new windows login accounts with reduced privileges to pass on to sonographers.

  • As a Research Platform all the software and options are installed.
  • The systems may be operated remotely by TeamViewer or similar Windows based remote-control viewers for field support.
  • All the software in the system is reprogrammable from the PC and implemented in the Graphical User Interface under Diagnostics. Updates are available on a USB stick or on our website. This includes the Power Sequencer’s Cortex, the Ultrasound Processing Boards FPGA, and some Transducers that contain Processors.
  • The System ships with an 8GB USB stick that contains the Deployment Plan (all software and drivers to operate the system, and the System’s Windows License).
  • There is an XML file in the UltraVision in the UltraVision.appdata folder that allows the OEM to edit the transducer characteristics, including pitch, geometry (linear, curved, phased, micro curved, origin, etc.) and operate the system with any transducer design within minutes.
  • The System contains two USB3 sockets which may be used to update the system, download DICOM patient data, connect a Ethernet Stick for Wi-FI communications dongle, or connect an adapter for external HDMI monitor.
  • The Power Sequencing Software is written in Arduino format and controls the power being applied and removed from components, the battery monitors, the 3/4D probe stepper motor controller. It is connected to the Windows PC via USB and can be updated at any time through this port.
  • The multi transducer input switch contains a MSP430 processor which is connected to the Windows PC via USB and can be updated at any time through this port.
  • Some Transducers contain a USB port and can be updated at any time through this port.