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 and caliper functions.
We also offer packaged programs with licenses that support Patient Management, Session Management, with a Data Base and output in DICOM.
Though the above software products come with 25 hours of online or telephone support we offer additional blocks for each 25 hours of product support.
The UltraVision is FDA approved and we are an ISO 13485 (and ISO 9001) compliant company. Modifications by the developer may invalidate the FDA approval 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 12-volts DC by 4 amps usually supplied by a IEC60601-1 desk top supply from mains power but if the developer chooses to use the battery option a similar 19-volt desk top supply will be required.
The system can be supplied with monitors, a PC, case and a battery supply.
All UltraVision Systems use the same printed circuit boards which are all programmable from the Thunderbolt 3 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.