Bracco obtains FDA clearance for Max 3 MRI contrast agent injector

The U.S. Food and Drug Administration (FDA) has cleared Bracco Diagnostics' Max 3 contrast agent injector for use in MRI procedures.

This 510(k) clearance of a Rapid Exchange and Syringeless Injector expands Bracco’s product portfolio with the addition of a green device in MRI suites that does not require the use of plastic containers. It will indirectly contribute to the reduction of a hospital’s or imaging center’s disposable processes and costs, the company said.

The Bracco branded Max3 Injector, manufactured in Germany by Ulrich GmbH & Co. KG, is the recipient of a Red Dot Design Award, an international design competition for product design and design concepts.

Its features include direct injection from original contrast media vials, which eliminate the need to refill syringes. Because the injector does not have power cables, it can be positioned anywhere in an MRI suite, up to a maximum magnetic field strength of 50 mT. A dedicated connector to the patient tubing provides contact protection and reliable protection against retrograde contamination.