Since its incorporation in 1996, Cleveland-based SREE Medical Systems has developed and manufactured MRI subsystems and accessories specifically for premature neonates, newborns and infants. Operating as Advanced Imaging Research, the company received the first FDA approval for a newborn-specific MRI imaging device in 2003 and builds, tests and inspects its final assemblies in Cleveland. Its ISO 13485-certified quality system supports collaborations with hospitals, universities and industry on pediatric MRI solutions.
ISO 13485
certification
US FDA 21 CFR 820 Quality System Regulation
compliance_program
Health Canada Medical Devices Regulations SOR/98-282
compliance_program
AAMI/IEC 60601
certification
CSA 22.2
certification
FDA 510(k)
registration
Health Canada Licensed
registration
CE
certification
Weinberg Medical PhysicsFounded in 2008, Weinberg Medical Physics is a medical-device incubator developing compact MRI systems, magnetic-particle technologies and related therapies for clinical use. Based in Rockville, the company combines ultrafast MRI with low-power electropermanent magnets and engineered nanoparticles, turning its work into self-sustaining ventures such as Promaxo, Radialis and Brain Biosciences.ROCKVILLE, MD
Quality Electrodynamics, LLCFounded in 2006 by physicist Dr. Hiroyuki Fujita, Quality Electrodynamics develops and manufactures MRI radiofrequency coils and related medical-imaging technology for diagnostic equipment makers and researchers. The Mayfield Village company became a Canon subsidiary in 2019 while retaining its name and local identity, and its work now includes the patented SureWave™ elastography system for MRI. QED is certified to ISO 13485 and the Medical Device Single Audit Program (MDSAP) by BSI.MAYFIELD VILLAGE, OH
RAPID MR International, LLCFounded in Columbus in 2006 by MR experts from Germany’s RAPID Biomedical, RAPID MR International designs and produces custom magnetic-resonance probeheads and coils for biomedical research and diagnosis. Its made-to-measure work draws on more than 1,200 RF-coil designs used in over 30 countries, spanning human and animal studies from low-field systems to ultra-high-field scanners. The company serves as an independent American link to its German sister company, supporting hospitals, research institutions, pharmaceutical companies and MR equipment manufacturers.COLUMBUS, OH
Atom Medical USAEstablished in 1938, Atom Medical develops and manufactures neonatal care equipment, with a focus on creating therapeutic environments for premature and newborn patients. The company’s history is especially tied to infant incubators, which helped it build a domestic market share exceeding 85% in Japan, while its products now reach more than 75 countries. Atom Medical USA provides direct U.S. support for the company’s neonatal product line and related mattress-barrier solutions.WARRENDALE, PA