Development and manufacturing of OEM ultrasound platforms and medical devices as a development partner
Cephasonics Ultrasound, Inc.
Minneapolis (MN) · San Jose (CA) · Blaine (MN)New on Amplifa
About Cephasonics
Cephasonics is an OEM provider of ultrasound platforms based in Minneapolis, Minnesota (USA). The company supports medical device manufacturers in integrating ultrasound directly into their devices — from surgical robotics to interventional cardiology to diagnostic and research systems. The scalable hardware platform comprises ultrasound engines with 64 to 4096 channels, controller boards, ultrasound carts and the Ultrasound Server for client-server architectures. In addition, Cephasonics offers a Software Development Kit (CUSDK), APIs, a GPU-based Image Processing Library as well as support for AI/deep-learning development in Python and TensorFlow. As an ISO 13485-certified partner, the company provides engineering and design consulting, feasibility studies, prototyping, design for manufacturing and turnkey manufacturing of complete medical devices including FDA 510(k) submission support. The core competency is quantitative ultrasound (QUS) for real-time measurement, telemetry and navigation data in integrated medical devices. Customers come from medical technology, surgical robotics, interventional cardiology, diagnostics, research and industrial applications worldwide.
- Site
- Minneapolis, MN
- Processes
- OEM ultrasound system development (ultrasound engines 64–4096 channels), Custom Ultrasound Engineering & Design Consulting (concept development, feasibility studies,, Custom hardware design (housings/prototyping, controller boards, integrated computers, displays,, ISO 13485 turnkey manufacturing of medical ultrasound products (incl. design for, Ultrasound software development (CUSDK, APIs, cQTuner, Image Processing Library, AI/deep learning, Application-ready ultrasound carts, CMUT transducer (capacitive micromachined ultrasonic transducers, via contact form as, Testing and FDA submission support (field testing, technical documentation, FDA 510(k))
- Materials
- Ultrasound Engines (64–4096 channels), Ultrasound Server (client-server architecture), Software Development Kit & APIs, Image Processing Library, Quantitative Ultrasound (QUS), CMUT Transducer, AI & deep-learning development
- Certificates
- ISO 13485:2016
- Industries
- Medical technology/OEM, Surgical robotics, Interventional cardiology, Diagnostics, Research, Industrial applications
- 01
Concept development & feasibility studies
- 02
Ultrasound system design & prototyping
- 03
Algorithm & software development (CUSDK, AI)
- 04
Hardware design (controller boards, housings, probe integration)
- 05
Design for Manufacturing & BOM creation
- 06
ISO 13485 turnkey manufacturing & FDA submission support
Platform & Technologies
Ultrasound Engines (64–4096 channels)
Scalable OEM hardware platform for high-resolution 3D and 4D imaging.
Ultrasound Server (client-server architecture)
Real-time ultrasound data as an integrated system resource for intelligent medical devices.
Software Development Kit & APIs
Over 1000 programmable parameters for customizing imaging, beamforming and image processing.
Image Processing Library
GPU-accelerated image enhancement with configurable modules for noise reduction, edge sharpening and stabilization.
Quantitative Ultrasound (QUS)
Real-time measurement of position, size, shape, volume and elasticity of tissue structures.
CMUT Transducer
Capacitive micromachined ultrasonic transducers as an area of interest for custom probe integration.
AI & deep-learning development
Development in C++, Python and TensorFlow for real-time measurement and telemetry applications.
Locations
Minneapolis (MN)
USBusiness address and contact
San Jose (CA)
USEngineering Design Center (ISO 13485-certified)
Blaine (MN)
USManufacturing Facility (ISO 13485-certified)
Products & Systems
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| OEM ultrasound system development (ultrasound engines 64–4096 channels)Engineering | – | – | – | – | – |
| Custom Ultrasound Engineering & Design Consulting (concept development, feasibility studies,Engineering | – | – | – | – | – |
| Custom hardware design (housings/prototyping, controller boards, integrated computers, displays,Engineering | – | – | – | – | – |
| ISO 13485 turnkey manufacturing of medical ultrasound products (incl. design forAssembly | – | – | – | Prototype – Full production | – |
| Ultrasound software development (CUSDK, APIs, cQTuner, Image Processing Library, AI/deep learningEngineering | – | – | – | – | – |
| Application-ready ultrasound cartsAssembly | – | – | – | – | – |
| CMUT transducer (capacitive micromachined ultrasonic transducers, via contact form asEngineering | – | – | – | – | – |
| Testing and FDA submission support (field testing, technical documentation, FDA 510(k))Testing | – | – | – | – | – |
| Quantitative ultrasound (QUS) / real-time measurement, telemetry and navigation data forEngineering | – | – | – | – | – |
Additional services
Quality & Certification
The quality management system is certified to ISO 13485:2016 for the design and manufacture of ultrasound hardware, software and systems. The most recent audit was completed with zero findings at both ISO 13485 sites.
| Evidence | San Jose (CA) | Blaine (MN) |
|---|---|---|
| ISO 13485:2016 |
History
- 2012
Cephasonics established as an independent company; over 15 years of experience in OEM ultrasound
- 2018
Expansion of the service and consulting programs