News | April 16, 2007

E-Z-EM Gets FDA 510(k) Clearance for EmpowerMR Injector System

April 17, 2007 - E-Z-EM Inc. announced that the FDA has given 510(k) clearance for its EmpowerMR injector system, E-Z-EM's first product for the magnetic resonance (MR) imaging market which extends the manufacturer’s Empower family of CT injector systems.

Like the rest of the Empower injector line family, the EmpowerMR is designed to provide an easy-to-use interface, robust safety features and EmpowerMR addresses the problem of electrical interference in the magnetic field of the MR scanner with a patent-pending hydraulic control system, instead of the shielded electrical control components used by most other MR injectors systems. EmpowerMR has no shielded iron core motors, piezoelectric motors or electrically active motor control circuitry adjacent to the scanner, which significantly minimizes the prospect of electrical interference with the scanner's magnetic field. EmpowerMR provides for utilization in MR field strengths of reportedly up to 7 Tesla. The systen is also not battery operated and links to its electrical supply by a single pass-through cable that does not require special shielding.

As there is no motor in the MR suite, EmpowerMR does not generate audible noise. EmpowerMR's hydraulic control also means the system can reportedly deliver consistent flow rates, volumetric and pressure performance on demand.

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