QVW

Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led

Product code: QVW
Device name: Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Contact ODE

FDA classification definition

Generator, measurement, and/or delivery system for hyperpolarized MR imaging agents, and accessories, are devices that generate a hyperpolarized MR imaging agent, monitor the dose equivalent volume of the dispensed dose, and/or store, transport or administer the imaging agent to the patient

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QVW

Classification and pathway per current FDA publications. Data from openFDA (CC0).