The UltraVision may be purchased as a component for a qualified Original Equipment Manufacturer’s product to develop ultrasound capabilities into their products or concepts and markets.
We offer the developer an Application Programming Interface (API) for controlling the acquisition of digital acoustic lines from the UltraVision console through to image generation. The source code for a Sample Application is in Windows Presentation Foundation (WPF) for the designer familiar with C#.
We also offer a View DX (VDX) and Sample Application for the designer familiar with Microsoft’s Direct X 11 or 12 to accept the digital acoustic lines from the console and create real-time images complete with B-Mode, M-Mode, CFD-Mode, PWD-Mode, Elastography-mode, Photoacoustics and caliper functions.
We also offer packaged programs with licenses that support Patient Management, Session Management, with a Data Base and output in DICOM.
The above software products come with 25 hours of online or telephone support we offer additional blocks of 25 hours of product support at reasonable prices.
The UltraVision product has an FDA 510k and we are an ISO 13485 (and ISO 9001) compliant company. Modifications by the developer or a different use case may invalidate the FDA 510k which will require the developer to resubmit the product. Further, we can provide guidance for the developer to comply with the Programmable Medical System (PEMS) section requirements of ISO 60601-1 in areas of Software Requirements Specifications, Software Design Specifications, Software Verification, and Software Validation. The labeling changes, change of intended use, technology performance changes will require the OEM to file a 510(k) where we stand ready to assist on a consulting basis.
Usually three boards (UP1: 9″ x 3.5″), UP2: 9″ x 2.5″ and UP72: 4.6″ x 3.8″) plus transducer interface implement a system. The basic system requires between 9 to 19-volts DC by 4 amps usually supplied by an IEC60601-1 desk top supply from mains power but if the developer chooses to use the battery option a similar 19-volt desktop supply will be required.
The system can be supplied with monitors, a PC, a case, and a battery supply. Most UltraVision Systems use the same printed circuit boards which are all programmable from the Thunderbolt 2, 3, or 4 or PCIe interfaces. The pulsers and receivers and connected to elements in the transducer, (in what is called a channel) via multiplexers again controlled by programmable devices. The main ultrasound processing board has channels connected to one very large Field Programmable Gate Array (FPGA) allowing again all algorithms to be programmed.
The UltraVision brings elastography and high-resolution imaging algorithms to this class of point-of-care ultrasonic scanners.
The solid machined aluminum case brings precision and durability, allowing the company to offer five (5) year warranties confidently. The powerful Intel i7 processor offers so many extensive features that are listed in the specification sheets.
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 or Original Equipment Manufacturer (OEM) agreements.
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:
- 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.
- 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 for regulatory approvals.
- Sub-assemblies and components of the UltraVision that the Partner may assemble into a marketable system.
- 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 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 vessels.
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 an RF emissions and susceptibility facility but we do have experience and maintain relations with regulatory approved laboratories that 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 OEM 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:
- 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).
- An API is available where a programmer can use a C++ interface to adapt new hardware, transducers and accommodate different languages and GUI designs.
- The system software includes a Direct X11 it may be used with tools in Windows 7, 8, and10.
- 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.
- 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.
- 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.
- 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 USB 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.