Neocoil, LLC - FDA 510(k) Cleared Devices

Neocoil, LLC designs and manufactures high-quality radiofrequency (RF) coils and audio systems for magnetic resonance imaging (MRI) applications. Founded in 2005, the company specializes in improving patient outcomes and imaging quality through innovative coil design and patient comfort solutions. Neocoil operates with a manufacturing facility in Pewaukee, Wisconsin.

The company has received 17 FDA 510(k) clearances from 17 total submissions, with no denied submissions on record. All cleared devices fall within the Radiology category. Neocoil's regulatory history spans from 2007 to 2026, with recent clearances demonstrating continued product innovation and active market presence.

Neocoil's product portfolio includes breast coils at multiple field strengths, shoulder coils, flexible coil systems, open coil suites for head and neck imaging, wireless audio systems for patient communication, and ECG gating devices. The company's GEM Flex product line represents a foundational innovation in coil design that has influenced subsequent product development.

Explore the complete list of device names, product codes, and individual clearance dates in the database to review Neocoil's full regulatory record.